FDA — authorised 7 December 1967
- Application: NDA016295
- Marketing authorisation holder: WAYLIS THERAP
- Local brand name: DROXIA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Physician's Choice medications in United States
FDA authorised Physician's Choice medications on 7 December 1967
Marketing authorisations
FDA — authorised 9 August 1996
- Application: ANDA074582
- Marketing authorisation holder: BARR
- Local brand name: DANAZOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 1998
- Application: ANDA075020
- Marketing authorisation holder: BARR LABS INC
- Local brand name: HYDROXYUREA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 October 1998
- Application: ANDA075143
- Marketing authorisation holder: BARR
- Local brand name: HYDROXYUREA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 February 1999
- Application: ANDA075340
- Marketing authorisation holder: PH HEALTH
- Local brand name: HYDROXYUREA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 2000
- Application: ANDA075734
- Marketing authorisation holder: BARR
- Local brand name: HYDROXYUREA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2005
- Application: ANDA077246
- Marketing authorisation holder: LANNETT CO INC
- 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 6 March 2024
- Application: ANDA218021
- Marketing authorisation holder: QILU
- Local brand name: HYDROXYUREA
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071569
- Marketing authorisation holder: AM THERAP
- Local brand name: DANAZOL
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is Physician's Choice medications approved in United States?
Yes. FDA authorised it on 7 December 1967; FDA authorised it on 9 August 1996; FDA authorised it on 30 July 1998.
Who is the marketing authorisation holder for Physician's Choice medications in United States?
WAYLIS THERAP holds the US marketing authorisation.