Data updated: Mar 10, 2026
MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE
Approved 1984-07-26
15
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-07-26
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
Companies
Novartis AMPHASTAR PHARMS INC Sun Pharma EUGIA PHARMA AMNEAL HONG KONG Hikma Teva XIROMED DURAMED PHARMS BARR Cipla UPSHER SMITH LABS
Active Ingredient: MEDROXYPROGESTERONE ACETATE
Website: ↗
MEDROXYPROGESTERONE ACETATE Approval History
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What MEDROXYPROGESTERONE ACETATE Treats
15 FDA approvalsOriginally approved for its first indication in 1984 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Jul 1984)
- • Approved indication (Aug 1996)
- • Approved indication (Dec 1999)Letter
- • Approved indication (Jul 2004)Letter
- • Approved indication (Oct 2004)
- • Approved indication (May 2009)
- • Approved indication (Nov 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Apr 2019)Letter
- • Approved indication (May 2019)
- • Approved indication (Aug 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Jun 2023)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
MEDROXYPROGESTERONE ACETATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.