Orange Book product · Brand (NDA)
GLUCOTROL
GLIPIZIDE
At a glance
May 11, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 1993
33 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
GLIPIZIDE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 017783
Product number
003
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.
- 1999GLUCOTROL XLBrand (NDA)
NDA 020329 · PFIZER
- 2026GLIPIZIDEGeneric (ANDA)
ANDA 219159 · GRAVITI PHARMS
- 2023GLIPIZIDEGeneric (ANDA)
ANDA 214874 · RUBICON RESEARCH
- 2018GLIPIZIDEGeneric (ANDA)
ANDA 203499 · ZYDUS PHARMS
- 2017GLIPIZIDEGeneric (ANDA)
ANDA 206928 · AUROBINDO PHARMA
- 2016GLIPIZIDEGeneric (ANDA)
ANDA 204720 · UNIQUE
- 2015GLIPIZIDEGeneric (ANDA)
ANDA 202298 · PHARMOBEDIENT
- 2013GLIPIZIDEGeneric (ANDA)
ANDA 076159 · PH HEALTH
- 2006GLIPIZIDEGeneric (ANDA)
ANDA 077820 · SUN PHARM INDS INC
- 2006GLIPIZIDEGeneric (ANDA)
ANDA 076467 · WATSON LABS
- 2001GLIPIZIDEGeneric (ANDA)
ANDA 075795 · APOTEX
- 1997GLIPIZIDEGeneric (ANDA)
ANDA 074550 · ACCORD HLTHCARE
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.
