GLIPIZIDE
Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus....
Details
- Status
- Prescription
- First Approved
- 1994-05-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
GLIPIZIDE Approval History
What GLIPIZIDE Treats
19 FDA approvalsOriginally approved for its first indication in 1994 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (May 1994)
- • Approved indication (Nov 1994)
- • Approved indication (Nov 1994)
- • Approved indication (Feb 1995)
- • Approved indication (Apr 1995)
- • Approved indication (Jun 1995)
- • Approved indication (Aug 1995)
- • Approved indication (Mar 1996)
- • Approved indication (Apr 1997)
- • Approved indication (Sep 1997)
- • Approved indication (Jun 2001)Letter
- • Approved indication (Sep 2003)
- • Approved indication (Jul 2006)
- • Approved indication (Sep 2013)
- • Approved indication (May 2015)
- • Approved indication (Dec 2016)
- • Approved indication (May 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Oct 2023)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GLIPIZIDE FDA Label Details
ProIndications & Usage
Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.