FDA — authorised 21 June 1976
- Status: approved
🇺🇸 Danzol in United States
FDA authorised Danzol on 21 June 1976
Marketing authorisations
FDA — authorised 9 August 1996
- Application: ANDA074582
- Marketing authorisation holder: BARR
- Local brand name: DANAZOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 2007
- Application: ANDA078214
- Marketing authorisation holder: LANNETT
- Local brand name: DANAZOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 October 2007
- Application: ANDA077246
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
Danzol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Danzol approved in United States?
Yes. FDA authorised it on 21 June 1976; FDA authorised it on 9 August 1996; FDA authorised it on 19 April 2007.
Who is the marketing authorisation holder for Danzol in United States?
Marketing authorisation holder not available in our data.