Details for New Drug Application (NDA): 078490
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NDA 078490 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, Strides Pharma Intl, Zydus, Zydus Pharms, Novitium Pharma, Aurobindo Pharma Ltd, Spil, Marksans Pharma, and P And L, and is included in forty-eight NDAs. It is available from ninety-two suppliers. There are two 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-five 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-five suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 078490
| Tradename: | OMEPRAZOLE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | omeprazole |
| Patents: | 0 |
Pharmacology for NDA: 078490
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 078490
Suppliers and Packaging for NDA: 078490
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 078490 | ANDA | NorthStar Rx LLC | 16714-123 | 16714-123-01 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-01) |
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 078490 | ANDA | NorthStar Rx LLC | 16714-123 | 16714-123-02 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 17, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 16, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 16, 2009 | TE: | AB | RLD: | No | ||||
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