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CAMPRAL

NDA

ACAMPROSATE CALCIUM | N021431 | FOREST LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 29, 2004

No patent or exclusivity listings for this strength.