Details for New Drug Application (NDA): 209400
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NDA 209400 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 209400
| Tradename: | OMEPRAZOLE |
| Applicant: | Dexcel |
| Ingredient: | omeprazole |
| Patents: | 2 |
Pharmacology for NDA: 209400
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 209400
Suppliers and Packaging for NDA: 209400
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | omeprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 209400 | NDA | L. Perrigo Company | 0113-0520 | 0113-0520-55 | 3 CARTON in 1 CARTON (0113-0520-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
| OMEPRAZOLE | omeprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 209400 | NDA | L. Perrigo Company | 0113-0520 | 0113-0520-74 | 14 BLISTER PACK in 1 CARTON (0113-0520-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 5, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,076,494 | Patent Expiration: | Dec 8, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,835,488 | Patent Expiration: | Dec 8, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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