Orange Book product · Brand (NDA)
CAMPRAL
ACAMPROSATE CALCIUM
At a glance
Jul 29, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2004
22 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ACAMPROSATE CALCIUM
Strength
333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021431
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 218984 · APPCO
- 2025ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 219904 · BIONPHARMA
- 2017ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 205995 · ZYDUS PHARMS
- 2014ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 200142 · MYLAN
- 2013ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 200143 · BARR LABS DIV TEVA
- 2013ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 202229 · GLENMARK PHARMS LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
