Data updated: May 26, 2026
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (sitagliptin, metformin hydrochloride)
Metabolic
Approved 2025-06-04
3
Indications
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2025-06-04
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, TABLET, COATED
Companies
INVENTIA HEALTHCARE LIMITED Novartis Apotex MSN LABORATORIES PRIVATE LTD AJANTA PHARMA LTD PH HEALTH SINOTHERAPEUTICS INC ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. NOVAST LABS LTD Aurobindo Pharma FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,
Active Ingredient: SITAGLIPTIN, METFORMIN HYDROCHLORIDE
Website: ↗
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE Approval History
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2025 to 2026
What SITAGLIPTIN AND METFORMIN HYDROCHLORIDE Treats
3 FDA approvalsOriginally approved for its first indication in 2025 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Jun 2025) New
- • Approved indication (Dec 2025) NewLetter
- • Approved indication (Apr 2026) New
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Pro Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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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.
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.