TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PREMPRO/PREMPHASE

CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE
Approved 2003-06-04
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-06-04
Routes
Oral
Dosage Forms
Tablet

Companies

Pfizer
Active Ingredient: CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE

PREMPRO/PREMPHASE Approval History

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What PREMPRO/PREMPHASE Treats

1 FDA approvals

Originally approved for its first indication in 2003 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

PREMPRO/PREMPHASE FDA Label Details

Pro

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Data Sources

FDA Approval: NDA021396 → Trials: ClinicalTrials.gov →

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