Orange Book product · Brand (NDA)
AMARYL
GLIMEPIRIDE
At a glance
Nov 30, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
GLIMEPIRIDE
Strength
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020496
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.
- 2013GLIMEPIRIDEGeneric (ANDA)
ANDA 078952 · HIKMA PHARMS
- 2013GLIMEPIRIDEGeneric (ANDA)
ANDA 202112 · REGCON HOLDINGS
- 2012GLIMEPIRIDEGeneric (ANDA)
ANDA 202759 · AUROBINDO PHARMA LTD
- 2012GLIMEPIRIDEGeneric (ANDA)
ANDA 091220 · MICRO LABS
- 2010GLIMEPIRIDEGeneric (ANDA)
ANDA 076995 · ACTAVIS LABS FL INC
- 2009GLIMEPIRIDEGeneric (ANDA)
ANDA 077911 · CARLSBAD
- 2007GLIMEPIRIDEGeneric (ANDA)
ANDA 078181 · ACCORD HLTHCARE
- 2006GLIMEPIRIDEGeneric (ANDA)
ANDA 077486 · MYLAN
- 2006GLIMEPIRIDEGeneric (ANDA)
ANDA 077280 · WATSON LABS
- 2005GLIMEPIRIDEGeneric (ANDA)
ANDA 077370 · PRINSTON INC
- 2005GLIMEPIRIDEGeneric (ANDA)
ANDA 077624 · QUAGEN
- 2005GLIMEPIRIDEGeneric (ANDA)
ANDA 077295 · CHARTWELL MOLECULAR
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.
