Details for New Drug Application (NDA): 076048
✉ Email this page to a colleague
NDA 076048 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, Norvium Bioscience, 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, Zydus, Zydus Pharms, Aurobindo Pharma Ltd, L Perrigo Co, Spil, and P And L, and is included in forty-six NDAs. It is available from ninety-nine 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 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 suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 076048
| Tradename: | OMEPRAZOLE |
| Applicant: | Apotex |
| Ingredient: | omeprazole |
| Patents: | 0 |
Pharmacology for NDA: 076048
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 076048
Suppliers and Packaging for NDA: 076048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 076048 | ANDA | Apotex Corp | 60505-0065 | 60505-0065-0 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-0) |
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 076048 | ANDA | Apotex Corp | 60505-0065 | 60505-0065-1 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0065-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 22, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 22, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
| Approval Date: | Jan 21, 2009 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
