Orange Book product · Brand (NDA)
PRANDIN
REPAGLINIDE
At a glance
Dec 22, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 1997
28 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
REPAGLINIDE
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020741
Product number
001
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.
- 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
- 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.
