TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PROGESTERONE

PROGESTERONE
Approved 1974-11-01
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
51
Years on Market

Details

Status
Discontinued
First Approved
1974-11-01
Routes
INJECTION, ORAL, VAGINAL
Dosage Forms
INJECTABLE, CAPSULE, INSERT

Companies

AM REGENT XIROMED Teva Eli Lilly Fresenius Kabi Dr. Reddy's AMNEAL PHARMS NY EUGIA PHARMA Hikma SOFGEN PHARMS BIONPHARMA ACCORD HLTHCARE
Active Ingredient: PROGESTERONE

PROGESTERONE Approval History

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What PROGESTERONE Treats

17 FDA approvals

Originally approved for its first indication in 1974 . Covers 17 distinct patient populations.

  • Other (17)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PROGESTERONE FDA Label Details

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Data Sources

FDA Approval: ANDA090845 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.