Details for New Drug Application (NDA): 203547
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NDA 203547 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 203547
| Tradename: | DIFLUNISAL |
| Applicant: | Zydus Pharms |
| Ingredient: | diflunisal |
| Patents: | 0 |
Pharmacology for NDA: 203547
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203547
Suppliers and Packaging for NDA: 203547
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFLUNISAL | diflunisal | TABLET;ORAL | 203547 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-530 | 68382-530-01 | 100 TABLET in 1 BOTTLE (68382-530-01) |
| DIFLUNISAL | diflunisal | TABLET;ORAL | 203547 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-530 | 68382-530-05 | 500 TABLET in 1 BOTTLE (68382-530-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jun 16, 2017 | TE: | AB | RLD: | No | ||||
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