Details for New Drug Application (NDA): 075876
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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 075876
Tradename: | OMEPRAZOLE |
Applicant: | Strides Pharma |
Ingredient: | omeprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075876
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 075876
Suppliers and Packaging for NDA: 075876
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075876 | ANDA | Strides Pharma Science Limited | 64380-222 | 64380-222-01 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (64380-222-01) |
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 075876 | ANDA | Strides Pharma Science Limited | 64380-223 | 64380-223-01 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (64380-223-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
Approval Date: | May 29, 2003 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
Approval Date: | May 29, 2003 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
Approval Date: | Jan 21, 2009 | TE: | RLD: | No |
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