Viewing data from:

ACAMPROSATE CALCIUM

ANDA

ACAMPROSATE CALCIUM | A202229 | GLENMARK PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs

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

ANGELINI ACRAF SPAACAMPROSATE CALCIUM

DMF 213482008

SYNTHIMED LABS PRIVATE LTDACAMPROSATE CALCIUM USP

DMF 214812008

OLON SPAACAMPROSATE CALCIUM

DMF 218072008

OLON SPAACAMPROSATE CALCIUM

DMF 226252009

EMCURE PHARMACEUTICALS LTDACAMPROSATE CALCIUM USP

DMF 258092012

MICRO LABS LTDACAMPROSATE CALCIUM USP

DMF 413062025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 18, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 333MG

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 16, 2013

No patent or exclusivity listings for this strength.