Active substance
Estrogens conjugated
- US FDA 7
- Safety 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PREMARIN | 1.25MG; 0.3MG; 0.625MG; 0.9MG; 0.45MG | tablet · oral | WYETH PHARMS | Prescription | 8 May 1942 |
| PREMARIN | 25MG/VIAL | injectable · injection | WYETH PHARMS | Prescription | 18 Dec 1956 |
| PREMARIN | 0.625MG/GM | cream · topical, vaginal | WYETH PHARMS | Prescription | 16 Oct 1978 |
| PREMARIN | 0.3MG; 0.45MG | tablet · oral | WYETH PHARMS INC | Prescription | 16 Jul 2003 |
| CONJUGATED ESTROGENS | 0.9MG; 1.25MG | tablet · oral | NOVAST LABS | Prescription | 15 Oct 2025 |
| CONJUGATED ESTROGENS | 0.3MG; 0.45MG; 0.625MG | tablet · oral | NOVAST LABS | Prescription | 15 Oct 2025 |
| PREMARIN | 2.5MG | tablet · oral | WYETH PHARMS | Discontinued | 8 May 1942 |
Safety signals and safety-related labeling changes
- US FDA 22 Apr 2025 PREMARIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Apr 2025 PREMARIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Apr 2025 PREMPHASE 14/14 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Apr 2025 PREMPRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 4 Mar 2024 DUAVEE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Feb 2024 PREMARIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.