Orange Book product · Generic (ANDA)
ACAMPROSATE CALCIUM
ACAMPROSATE CALCIUM
At a glance
May 26, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2017
9 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ACAMPROSATE CALCIUM
Strength
333MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 205995
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACAMPROSATE CALCIUM
- 2004CAMPRALBrand (NDA)
NDA 021431 · FOREST LABS
- 2026ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 218984 · APPCO
- 2025ACAMPROSATE CALCIUMGeneric (ANDA)
ANDA 219904 · BIONPHARMA
- 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.
