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Details for New Drug Application (NDA): 022032
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NDA 022032 describes OMEPRAZOLE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Cumberland Pharms, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Unicorn, Zydus Pharms, Spil, and P And L, and is included in forty-four NDAs. It is available from eighty-four 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. Thirty-seven 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 022032
| Tradename: | OMEPRAZOLE |
| Applicant: | Dexcel Pharma |
| Ingredient: | omeprazole |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022032
Suppliers and Packaging for NDA: 022032
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 022032 | NDA | L. Perrigo Company | 0113-0915 | 0113-0915-03 | 3 BOTTLE in 1 CARTON (0113-0915-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
| OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 022032 | NDA | L. Perrigo Company | 0113-0915 | 0113-0915-30 | 2 CARTON in 1 CARTON (0113-0915-30) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 022032
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| OMEPRAZOLE | TABLET, DELAYED RELEASE;ORAL | omeprazole | 022032 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 4, 2007 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Aug 16, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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