Viewing data from:

DIFLUNISAL

ANDA

DIFLUNISAL | A073563 | DASTECH INTERNATIONAL INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 - DIFLUNISAL- diflunisal tablet, film coated RE Suitability Peti... FDA-2023-P-4280 · 11 docket documents Pharmobedient Consulting, LLC filed a citizen petition regarding diflunisal tablets, film coated, requesting that the FDA determine the suitability of this drug product for regulatory purposes. The petition addresses the regulatory classification and eligibility of diflunisal tablets under the appli	Suitability	2023-10-02	Granted	Pharmobedient Consulting, LLC

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

API Supply Chain4 active DMFs4 inactive

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

CHEMI SPADIFLUNISAL

DMF 74921988

AARTI PHARMALABS LTDDIFLUNISAL

DMF 247622011

MATRIX PHARMACORP PRIVATE LTDDIFLUNISAL, USP

DMF 289512015

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: Nov 27, 1992

No patent or exclusivity listings for this strength.