Details for New Drug Application (NDA): 073673
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NDA 073673 describes DIFLUNISAL, which is a drug marketed by Ani Pharms, Dastech Intl, Heritage Pharma, Purepac Pharm, Teva, Watson Labs, and Zydus Pharms, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the DIFLUNISAL profile page.
The generic ingredient in DIFLUNISAL is diflunisal. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the diflunisal profile page.
The generic ingredient in DIFLUNISAL is diflunisal. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the diflunisal profile page.
Summary for 073673
| Tradename: | DIFLUNISAL |
| Applicant: | Teva |
| Ingredient: | diflunisal |
| Patents: | 0 |
Pharmacology for NDA: 073673
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 073673
Suppliers and Packaging for NDA: 073673
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFLUNISAL | diflunisal | TABLET;ORAL | 073673 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-9222 | 0093-9222-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01) |
| DIFLUNISAL | diflunisal | TABLET;ORAL | 073673 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-9222 | 0093-9222-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 31, 1992 | TE: | AB | RLD: | No | ||||
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