Details for New Drug Application (NDA): 075757
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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. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 075757
Tradename: | OMEPRAZOLE |
Applicant: | Sandoz |
Ingredient: | omeprazole |
Patents: | 0 |
Pharmacology for NDA: 075757
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 075757
Suppliers and Packaging for NDA: 075757
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075757 | ANDA | Sandoz Inc | 0781-2785 | 0781-2785-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2785-01) |
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075757 | ANDA | Sandoz Inc | 0781-2785 | 0781-2785-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2785-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 28, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 28, 2003 | TE: | AB | RLD: | No |
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