Details for New Drug Application (NDA): 074431
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NDA 074431 describes FLURBIPROFEN, which is a drug marketed by Ivax Sub Teva Pharms, Natco Pharma, Pliva, Rising, Sun Pharm Inds Inc, Teva, Theragen, and Bausch And Lomb, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the FLURBIPROFEN profile page.
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.
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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