Orange Book product · Brand (NDA)
PRECOSE
ACARBOSE
At a glance
May 29, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 29, 1997
29 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ACARBOSE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020482
Product number
004
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.
- 2020ACARBOSEGeneric (ANDA)
ANDA 213821 · HANGZHOU ZHONGMEI
- 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.
