FDA — authorised 15 August 1979
- Application: ANDA085470
- Marketing authorisation holder: PFIZER
- Local brand name: DEPO-ESTRADIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Depoestradiol in United States
FDA authorised Depoestradiol on 15 August 1979
Marketing authorisations
FDA — authorised 15 August 1979
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
FDA — authorised 13 June 1980
- Application: NDA017968
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: DEPO-TESTADIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 November 1981
- Application: ANDA085620
- Marketing authorisation holder: DR REDDYS
- Local brand name: ESTRADIOL CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 1986
- Application: ANDA085603
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 October 2000
- Application: NDA020874
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: LUNELLE
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
FDA
- Application: ANDA089310
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: ESTRADIOL CYPIONATE
- Indication: Injectable — Injection
- Status: approved
Depoestradiol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Depoestradiol approved in United States?
Yes. FDA authorised it on 15 August 1979; FDA authorised it on 15 August 1979; FDA authorised it on 13 June 1980.
Who is the marketing authorisation holder for Depoestradiol in United States?
PFIZER holds the US marketing authorisation.