Viewing data from:

DIFLUNISAL

ANDA

DIFLUNISAL | A203547 | ZYDUS PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 22, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 16, 2017

No patent or exclusivity listings for this strength.