Details for New Drug Application (NDA): 211732
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The generic ingredient in OMEPRAZOLE MAGNESIUM 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 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 | Camber Consumer Care Inc | 69230-318 | 69230-318-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05) |
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 |
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