2004 3rd quarter
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| safetyreportid | transmissiondateformat | transmissiondate | serious | receivedateformat | receivedate | receiptdateformat | receiptdate | fulfillexpeditecriteria | companynumb | primarysource.qualification | sender.senderorganization | receiver | patient.patientsex | patient.reaction.reactionmeddrapt | patient.drug.drugcharacterization | patient.drug.medicinalproduct | patient.drug.drugauthorizationnumb | patient.drug.drugdosagetext | patient.drug.drugindication | patient.drug.openfda.application_number | patient.drug.openfda.brand_name | patient.drug.openfda.generic_name | patient.drug.openfda.manufacturer_name | patient.drug.openfda.product_ndc | patient.drug.openfda.product_type | patient.drug.openfda.route | patient.drug.openfda.substance_name | patient.drug.openfda.rxcui | patient.drug.openfda.spl_id | patient.drug.openfda.spl_set_id | patient.drug.openfda.package_ndc | patient.drug.openfda.nui | patient.drug.openfda.pharm_class_epc | patient.drug.openfda.pharm_class_moa | patient.drug.openfda.unii | patient.drug.openfda.pharm_class_cs | patient.patientonsetage | patient.patientonsetageunit |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4513405-5 | 102 | 20050328 | 2 | 102 | 20041130 | 102 | 20040916 | 2 | US-BRISTOL-MYERS SQUIBB COMPANY-12704565 | 3 | FDA-Public Use | 1 | NAIL DISORDER | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 64 | 801 | |||||
| 4467342-5 | 102 | 20050328 | 1 | 102 | 20041004 | 102 | 20040921 | 1 | USA-2002-0001486 | 1 | FDA-Public Use | 1 | WHEEZING | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 56 | 801 | |||||
| 4464079-3 | 102 | 20050211 | 1 | 102 | 20040930 | 102 | 20040930 | 2 | 3 | FDA-Public Use | 1 | PNEUMONIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | ||||||||
| 4497315-8 | 102 | 20050211 | 2 | 102 | 20040927 | 102 | 20040723 | 2 | USA040773465 | FDA-Public Use | 1 | PALLOR | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 10 | 801 | ||||||
| 4425190-6 | 102 | 20050211 | 1 | 102 | 20040812 | 102 | 20040812 | 2 | 3 | FDA-Public Use | 2 | SCLERAL HAEMORRHAGE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 55 | 801 | ||||||
| 4390748-X | 102 | 20050211 | 1 | 102 | 20040706 | 102 | 20040706 | 2 | 3 | FDA-Public Use | 1 | BILE DUCT OBSTRUCTION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | ||||||||
| 4390748-X | 102 | 20050211 | 1 | 102 | 20040706 | 102 | 20040706 | 2 | 3 | FDA-Public Use | 1 | ESCHERICHIA INFECTION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | ||||||||
| 4390748-X | 102 | 20050211 | 1 | 102 | 20040706 | 102 | 20040706 | 2 | 3 | FDA-Public Use | 1 | JAUNDICE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | ||||||||
| 4390748-X | 102 | 20050211 | 1 | 102 | 20040706 | 102 | 20040706 | 2 | 3 | FDA-Public Use | 1 | PYREXIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | ||||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | ANXIETY | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | ASTHENIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | BLOOD ALBUMIN DECREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | BLOOD ALKALINE PHOSPHATASE INCREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | BLOOD LACTATE DEHYDROGENASE INCREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | CARDIAC FAILURE CONGESTIVE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | CHEST PAIN | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | CONSTIPATION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | DEPRESSION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | FATIGUE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | GASTRIC ULCER | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | HAEMATOCRIT DECREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | HIATUS HERNIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7341 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | HYPERTENSION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-3 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | HYPOXIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-8 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | INTESTINAL OBSTRUCTION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-1 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | MULTIPLE SCLEROSIS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-1 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | MUSCLE SPASMS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-5 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | NERVOUSNESS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-6 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | OESOPHAGITIS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7341-2 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | PLEURAL EFFUSION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-9 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4480476-4 | 102 | 20050328 | 1 | 102 | 20041018 | 102 | 20040930 | 1 | 201359 | 1 | FDA-Public Use | 2 | PNEUMONIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | |||||||
| 4583315-6 | 102 | 20050727 | 2 | 102 | 20050125 | 102 | 20040930 | 2 | USA040465039 | FDA-Public Use | 2 | ABDOMINAL PAIN | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-4 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 69 | 801 | ||||||
| 4583315-6 | 102 | 20050727 | 2 | 102 | 20050125 | 102 | 20040930 | 2 | USA040465039 | FDA-Public Use | 2 | BONE DENSITY DECREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7268 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-3 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 69 | 801 | ||||||
| 4517417-7 | 102 | 20050328 | 2 | 102 | 20041022 | 102 | 20040826 | 2 | 800099 | 3 | FDA-Public Use | 2 | PRURITUS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-1 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 42 | 801 | |||||
| 4517417-7 | 102 | 20050328 | 2 | 102 | 20041022 | 102 | 20040826 | 2 | 800099 | 3 | FDA-Public Use | 2 | RASH | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7268 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-7 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 42 | 801 | |||||
| 4475196-6 | 102 | 20050211 | 2 | 102 | 20040923 | 102 | 20040707 | 2 | USA040771956 | FDA-Public Use | 2 | INJECTION SITE NODULE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-9 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 82 | 801 | ||||||
| 4478441-6 | 102 | 20050328 | 1 | 102 | 20041019 | 102 | 20040827 | 1 | PHEH2004US09397 | FDA-Public Use | 2 | BLOOD PRESSURE INCREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7341-2 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 53 | 801 | ||||||
| 4478441-6 | 102 | 20050328 | 1 | 102 | 20041019 | 102 | 20040827 | 1 | PHEH2004US09397 | FDA-Public Use | 2 | CONVULSION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 53 | 801 | ||||||
| 4478441-6 | 102 | 20050328 | 1 | 102 | 20041019 | 102 | 20040827 | 1 | PHEH2004US09397 | FDA-Public Use | 2 | LOWER LIMB FRACTURE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-6 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 53 | 801 | ||||||
| 4478441-6 | 102 | 20050328 | 1 | 102 | 20041019 | 102 | 20040827 | 1 | PHEH2004US09397 | FDA-Public Use | 2 | TREMOR | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-2 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 53 | 801 | ||||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | BLOOD PRESSURE DIASTOLIC INCREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-5 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | BODY TINEA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-7 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | CHEST PAIN | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7268 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-3 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | DYSPNOEA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-1 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | FEELING ABNORMAL | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-4 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | HEADACHE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-7 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | HYPERSENSITIVITY | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-4 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | MUSCULOSKELETAL STIFFNESS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-3 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | NAUSEA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-4 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | PRURITUS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-1 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4471377-6 | 102 | 20050328 | 1 | 102 | 20041006 | 102 | 20040924 | 1 | US-GDP-0411395 | 5 | FDA-Public Use | 2 | SKIN LESION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-2 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 47 | 805 | |||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | ABDOMINAL PAIN | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-6 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | ABNORMAL FAECES | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-3 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | ANAL HAEMORRHAGE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-4 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | BACK PAIN | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-1 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | COLITIS ULCERATIVE | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-7268 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-2 | N0000010288 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | DEHYDRATION | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7341-2 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | DIZZINESS | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-9 | N0000175811 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | HAEMATOCHEZIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-4357-3 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | PYREXIA | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876195 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7268-3 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | VOMITING | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-4 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 | ||||||
| 4475412-0 | 102 | 20050328 | 1 | 102 | 20041015 | 102 | 20040910 | 1 | PHEH2004US09768 | FDA-Public Use | 2 | WHITE BLOOD CELL COUNT INCREASED | 2 | MIRALAX | NDA022015 | MIRALAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | 11523-4357 | HUMAN OTC DRUG | ORAL | POLYETHYLENE GLYCOL 3350 | 876193 | ffc1badf-8763-7e16-e053-6294a90ad59f | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 11523-7234-2 | N0000009871 | Osmotic Laxative [EPC] | Osmotic Activity [MoA] | G2M7P15E5P | 28 | 801 |