Details for New Drug Application (NDA): 076515
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The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 076515
Tradename: | OMEPRAZOLE |
Applicant: | Sandoz |
Ingredient: | omeprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076515
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 076515
Suppliers and Packaging for NDA: 076515
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 076515 | ANDA | Sandoz Inc | 0781-2234 | 0781-2234-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-01) |
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 076515 | ANDA | Sandoz Inc | 0781-2234 | 0781-2234-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2234-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 21, 2009 | TE: | AB | RLD: | No |
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