FDA — authorised 26 December 1974
- Application: NDA017439
- Marketing authorisation holder: ALLERGAN
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Delalutin in United States
FDA authorised Delalutin on 26 December 1974
Marketing authorisations
FDA — authorised 3 October 1975
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
FDA — authorised 24 August 2015
- Application: ANDA200271
- Marketing authorisation holder: ASPEN GLOBAL INC
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA — authorised 9 May 2019
- Application: ANDA211142
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA
- Application: ANDA089331
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: NDA010347
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: DELALUTIN
- Indication: SOLUTION — INTRAMUSCULAR
- Status: approved
FDA
- Application: NDA018004
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089330
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: HYDROXYPROGESTERONE CAPROATE
- Indication: Injectable — Injection
- Status: approved
Delalutin 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 Delalutin approved in United States?
Yes. FDA authorised it on 26 December 1974; FDA authorised it on 3 October 1975; FDA authorised it on 24 August 2015.
Who is the marketing authorisation holder for Delalutin in United States?
ALLERGAN holds the US marketing authorisation.