Last Updated: September 24, 2026

Details for New Drug Application (NDA): 219904

✉ Email this page to a colleague

« Back to Dashboard

NDA 219904 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 219904

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

Suppliers and Packaging for NDA: 219904

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	219904	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8660	0615-8660-39	30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8660-39)
ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	219904	ANDA	Bionpharma Inc.,	69452-353	69452-353-25	180 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-353-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	333MG
Approval Date:	Sep 18, 2025	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.