FDA — authorised 17 October 1974
- Application: ANDA080767
- Marketing authorisation holder: IMPAX LABS
- Status: supplemented
🇺🇸 "drug holidays" (D) in United States
FDA authorised "drug holidays" (D) on 17 October 1974
Marketing authorisations
FDA — authorised 28 April 1983
- Application: ANDA088100
- Marketing authorisation holder: HOSPIRA
- Status: supplemented
FDA — authorised 17 August 2005
- Application: ANDA076923
- Marketing authorisation holder: XGEN PHARMS
- Status: approved
FDA — authorised 14 October 2009
- Application: ANDA078418
- Marketing authorisation holder: STRIDES PHARMA
- Status: supplemented
FDA — authorised 1 December 2011
- Application: NDA200403
- Marketing authorisation holder: HOSPIRA INC
- Status: supplemented
Frequently asked questions
Is "drug holidays" (D) approved in United States?
Yes. FDA authorised it on 17 October 1974; FDA authorised it on 28 April 1983; FDA authorised it on 17 August 2005.
Who is the marketing authorisation holder for "drug holidays" (D) in United States?
IMPAX LABS holds the US marketing authorisation.