FDA approval · Drugs@FDA
PREMPRO/PREMPHASEconjugated estrogens/medroxyprogesterone acetate
NDA021396 ·
FDA approved the original new drug application for PREMPRO/PREMPHASE on June 4, 2003, sponsored by WYETH AYERST. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA021396
- Sponsor
- WYETH AYERST
- Original approval
- Review
- standard review
- Submission class
- Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
- Active ingredient
- conjugated estrogens/medroxyprogesterone acetate
Browse every approval whose brand starts with P, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| conjugated estrogens/medroxyprogesterone acetate 0.45MG/1.5MG & 0.3MG/1.5MG | Tablet | Oral | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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