Orange Book product · Generic (ANDA)
REPAGLINIDE
REPAGLINIDE
At a glance
Jul 11, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 11, 2013
13 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
REPAGLINIDE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 077571
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of REPAGLINIDE
- 1997PRANDINBrand (NDA)
NDA 020741 · GEMINI LABS LLC
- 2023REPAGLINIDEGeneric (ANDA)
ANDA 207209 · MACLEODS PHARMS LTD
- 2015REPAGLINIDEGeneric (ANDA)
ANDA 091517 · KENTON
- 2014REPAGLINIDEGeneric (ANDA)
ANDA 090008 · ACTAVIS TOTOWA
- 2014REPAGLINIDEGeneric (ANDA)
ANDA 203820 · AUROBINDO PHARMA LTD
- 2013REPAGLINIDEGeneric (ANDA)
ANDA 078555 · CHARTWELL RX
- 2013REPAGLINIDEGeneric (ANDA)
ANDA 090252 · QUAGEN
- 2013REPAGLINIDEGeneric (ANDA)
ANDA 201189 · PADAGIS US
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.
