Details for New Drug Application (NDA): 211732
NDA 211732 describes OMEPRAZOLE MAGNESIUM, which is a drug marketed by Aurobindo Pharma Ltd, Dexcel, Dr Reddys Labs Ltd, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, Perrigo R And D, and Pharmazone, and is included in nine NDAs. It is available from sixty suppliers. Additional details are available on the OMEPRAZOLE MAGNESIUM profile page.
The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There is one drug master file entry for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There is one drug master file entry for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 211732
| Tradename: | OMEPRAZOLE MAGNESIUM |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | omeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 211732
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 211732
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 211732 | ANDA | A-S Medication Solutions | 50090-6888 | 50090-6888-0 | 2 BOTTLE in 1 CARTON (50090-6888-0) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
| OMEPRAZOLE MAGNESIUM | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 211732 | ANDA | Allegiant Health | 69168-476 | 69168-476-14 | 1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Mar 25, 2020 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
