Details for New Drug Application (NDA): 202845
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NDA 202845 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 202845
| Tradename: | DIFLUNISAL |
| Applicant: | Heritage Pharma |
| Ingredient: | diflunisal |
| Patents: | 0 |
Pharmacology for NDA: 202845
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202845
Suppliers and Packaging for NDA: 202845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFLUNISAL | diflunisal | TABLET;ORAL | 202845 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-673 | 14539-673-01 | 100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01) |
| DIFLUNISAL | diflunisal | TABLET;ORAL | 202845 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-673 | 14539-673-05 | 500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 8, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Aug 16, 2024 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 375MG | ||||
| Approval Date: | Aug 16, 2024 | TE: | RLD: | No | |||||
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