Active substance
Estrogens conjugated synthetic b
- US FDA 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ENJUVIA | 0.3MG; 0.45MG; 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.9MG | tablet · oral | ASPEN | Discontinued | 10 May 2004 |
| ENJUVIA | 0.3MG; 0.45MG | tablet · oral | DURAMED | Discontinued | 20 Dec 2004 |
Safety signals and safety-related labeling changes
- US FDA 14 Nov 2025 ENJUVIA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Use in Specific Populations; 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.