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Last Updated: December 16, 2025

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.
Summary for 202845
Tradename:DIFLUNISAL
Applicant:Heritage Pharma
Ingredient:diflunisal
Patents:0
Pharmacology for NDA: 202845
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 202845
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
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:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 8, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 16, 2024TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Aug 16, 2024TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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