Details for New Drug Application (NDA): 204661
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NDA 204661 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Pharmobedient, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma Intl, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Marksans Pharma, and P And L, and is included in forty-seven NDAs. It is available from ninety-three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OMEPRAZOLE profile page.
The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 204661
| Tradename: | OMEPRAZOLE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | omeprazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 204661
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 13, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
| Approval Date: | Jun 13, 2017 | TE: | RLD: | No | |||||
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