Details for New Drug Application (NDA): 202845
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The generic ingredient in DIFLUNISAL is diflunisal. There are seven drug master file entries for this compound. Five 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 |
Formulation / Manufacturing: | see details |
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 |
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