FDA — authorised 24 March 1976
- Application: NDA017630
- Marketing authorisation holder: GE HEALTHCARE
- Status: supplemented
🇺🇸 "Basel phenotyping cocktail" capsule in United States
FDA authorised "Basel phenotyping cocktail" capsule on 24 March 1976
Marketing authorisations
FDA — authorised 2 December 1976
- Application: ANDA085285
- Marketing authorisation holder: KV PHARM
- Status: approved
FDA — authorised 14 October 2009
- Application: ANDA078418
- Marketing authorisation holder: STRIDES PHARMA
- Status: supplemented
FDA — authorised 28 June 2013
- Application: ANDA202338
- Marketing authorisation holder: RISING
- Status: supplemented
FDA — authorised 30 September 2016
- Application: ANDA203434
- Marketing authorisation holder: NOVAST LABS
- Status: supplemented
Frequently asked questions
Is "Basel phenotyping cocktail" capsule approved in United States?
Yes. FDA authorised it on 24 March 1976; FDA authorised it on 2 December 1976; FDA authorised it on 14 October 2009.
Who is the marketing authorisation holder for "Basel phenotyping cocktail" capsule in United States?
GE HEALTHCARE holds the US marketing authorisation.