Orange Book product · Generic (ANDA)
REPAGLINIDE
REPAGLINIDE
At a glance
Nov 22, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2013
12 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
REPAGLINIDE
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078555
Product number
001
Marketing status
RX
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 090252 · QUAGEN
- 2013REPAGLINIDEGeneric (ANDA)
ANDA 201189 · PADAGIS US
- 2013REPAGLINIDEGeneric (ANDA)
ANDA 077571 · SUN PHARM INDS INC
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.
