FDA — authorised 15 July 1954
- Marketing authorisation holder: PAR STERILE PRODUCTS
- Status: approved
🇺🇸 Delestrogen in United States
FDA authorised Delestrogen on 15 July 1954
Marketing authorisations
FDA — authorised 15 July 1954
- Application: NDA009402
- Marketing authorisation holder: PH HEALTH
- Local brand name: DELESTROGEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 January 2010
- Application: ANDA090920
- Marketing authorisation holder: AM REGENT
- Status: approved
FDA — authorised 13 February 2012
- Application: NDA022252
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Efficacy
- Status: approved
FDA — authorised 21 April 2020
- Application: ANDA203723
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 24 October 2024
- Application: ANDA216656
- Marketing authorisation holder: XIROMED
- Indication: Labeling
- Status: approved
The FDA approved Delestrogen, a drug product, for labeling indication on October 24, 2024. The marketing authorization holder is XIROMED. The approval was granted under the standard expedited pathway.
Delestrogen 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 Delestrogen approved in United States?
Yes. FDA authorised it on 15 July 1954; FDA authorised it on 15 July 1954; FDA authorised it on 19 January 2010.
Who is the marketing authorisation holder for Delestrogen in United States?
PAR STERILE PRODUCTS holds the US marketing authorisation.