Details for New Drug Application (NDA): 212977
✉ Email this page to a colleague
NDA 212977 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 212977
| Tradename: | OMEPRAZOLE |
| Applicant: | Xiromed |
| Ingredient: | omeprazole |
| Patents: | 0 |
Pharmacology for NDA: 212977
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 212977
Suppliers and Packaging for NDA: 212977
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 212977 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8406 | 0615-8406-05 | 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-05) |
| OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 212977 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8406 | 0615-8406-07 | 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8406-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 10, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
| Approval Date: | Dec 27, 2024 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
