FDA — authorised 16 December 2010
- Application: NDA022574
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Drospirenone Ethinyl estradiol in United States
FDA authorised Drospirenone Ethinyl estradiol on 16 December 2010
Marketing authorisations
FDA — authorised 13 June 2018
- Application: ANDA205947
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 29 April 2022
- Application: NDA022532
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 7 September 2023
- Application: ANDA205948
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
Drospirenone Ethinyl estradiol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Drospirenone Ethinyl estradiol approved in United States?
Yes. FDA authorised it on 16 December 2010; FDA authorised it on 13 June 2018; FDA authorised it on 29 April 2022.
Who is the marketing authorisation holder for Drospirenone Ethinyl estradiol in United States?
BAYER HLTHCARE holds the US marketing authorisation.