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Last Updated: November 6, 2025

Details for New Drug Application (NDA): 200142

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NDA 200142 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.

The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.

Summary for 200142

Tradename:	ACAMPROSATE CALCIUM
Applicant:	Mylan
Ingredient:	acamprosate calcium
Patents:	0

Suppliers and Packaging for NDA: 200142

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	200142	ANDA	Mylan Pharmaceuticals Inc.	0378-6333	0378-6333-80	180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	200142	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8560	0615-8560-39	30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8560-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Mar 11, 2014	TE:	AB	RLD:	No

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