Details for New Drug Application (NDA): 078490
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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-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 078490
Tradename: | OMEPRAZOLE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | omeprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078490
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 078490
Suppliers and Packaging for NDA: 078490
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 078490 | ANDA | NorthStar Rx LLC | 16714-123 | 16714-123-01 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-01) |
OMEPRAZOLE | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 078490 | ANDA | NorthStar Rx LLC | 16714-123 | 16714-123-02 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-123-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG | ||||
Approval Date: | Apr 17, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 16, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG | ||||
Approval Date: | Mar 16, 2009 | TE: | AB | RLD: | No |
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