Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218984

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NDA 218984 describes ACAMPROSATE CALCIUM, which is a drug marketed by Appco, Barr Labs Div Teva, Bionpharma, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.

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

Summary for 218984

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

Suppliers and Packaging for NDA: 218984

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	218984	ANDA	Somerset Therapeutics, LLC	70069-860	70069-860-18	180 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-18)
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	218984	ANDA	Somerset Therapeutics, LLC	70069-860	70069-860-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE (70069-860-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Mar 16, 2026	TE:	AB	RLD:	No

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