FDA — authorised 31 May 1957
- Application: NDA010971
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PMB 400
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ESTROGENS, CONJUGATED in United States
FDA authorised ESTROGENS, CONJUGATED on 31 May 1957 · 1,541 US adverse-event reports
Marketing authorisations
FDA — authorised 30 December 1994
- Application: NDA020303
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: PREMPHASE (PREMARIN;CYCRIN 14/14)
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 May 1998
- Application: NDA004782
- Marketing authorisation holder: WYETH PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 15 October 2025
- Application: ANDA214025
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 15 October 2025
- Application: ANDA214023
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA
- Application: NDA011045
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: MILPREM-400
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,541
Most-reported reactions
- Breast Cancer Female — 412 reports (26.74%)
- Drug Ineffective — 212 reports (13.76%)
- Headache — 141 reports (9.15%)
- Fatigue — 133 reports (8.63%)
- Nausea — 131 reports (8.5%)
- Breast Cancer — 114 reports (7.4%)
- Dizziness — 111 reports (7.2%)
- Pain — 99 reports (6.42%)
- Dyspnoea — 96 reports (6.23%)
- Diarrhoea — 92 reports (5.97%)
ESTROGENS, CONJUGATED in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ESTROGENS, CONJUGATED approved in United States?
Yes. FDA authorised it on 31 May 1957; FDA authorised it on 30 December 1994; FDA authorised it on 6 May 1998.
Who is the marketing authorisation holder for ESTROGENS, CONJUGATED in United States?
WYETH AYERST holds the US marketing authorisation.