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DIFLUNISAL

ANDA

DIFLUNISAL | A073673 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4280 Pharmobedient Consulting, LLC submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an ANDA for Diflunisal Orally Disintegrating Tablets in 250 mg and 500 mg strengths, which differ in dosage form from the reference st	Suitability	2023-10-02	Open	Pharmobedient Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

CHEMI SPADIFLUNISAL

DMF 74921988

AARTI PHARMALABS LTDDIFLUNISAL

DMF 247622011

COHANCE LIFESCIENCES LTDDIFLUNISAL USP

DMF 348182020

MERCK SHARP & DOHME RESEARCH LABSInactiveDIFLUNISAL

DMF 38521980

CAMBREX PROFARMACO MILANO SRLInactiveDIFLUNISAL

DMF 81631989

ZAMBON GROUP SPAInactiveDIFLUNISAL

DMF 90601991

JUHUA GROUP CORP PHARMACEUTICAL FACTORYInactiveDIFLUNISAL USP

DMF 257432012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 1992

No patent or exclusivity listings for this strength.