Details for New Drug Application (NDA): 074431
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The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
Summary for 074431
Tradename: | FLURBIPROFEN |
Applicant: | Teva |
Ingredient: | flurbiprofen |
Patents: | 0 |
Pharmacology for NDA: 074431
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074431
Suppliers and Packaging for NDA: 074431
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLURBIPROFEN | flurbiprofen | TABLET;ORAL | 074431 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0711 | 0093-0711-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0711-01) |
FLURBIPROFEN | flurbiprofen | TABLET;ORAL | 074431 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0711 | 0093-0711-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0711-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 31, 1995 | TE: | RLD: | No |
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