Orange Book product · Generic (ANDA)
ACARBOSE
ACARBOSE
At a glance
Aug 18, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 18, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ACARBOSE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213821
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACARBOSE
- 1997PRECOSEBrand (NDA)
NDA 020482 · BAYER HLTHCARE
- 2013ACARBOSEGeneric (ANDA)
ANDA 091343 · SOMERSET THERAPS LLC
- 2012ACARBOSEGeneric (ANDA)
ANDA 202271 · AVET LIFESCIENCES
- 2011ACARBOSEGeneric (ANDA)
ANDA 090912 · STRIDES PHARMA
- 2011ACARBOSEGeneric (ANDA)
ANDA 091053 · NATCO PHARMA USA
- 2009ACARBOSEGeneric (ANDA)
ANDA 078441 · IMPAX LABS
- 2008ACARBOSEGeneric (ANDA)
ANDA 078470 · HIKMA
- 2008ACARBOSEGeneric (ANDA)
ANDA 077532 · WATSON LABS
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.
