FDA — authorised 13 January 1998
- Application: ANDA074631
- Marketing authorisation holder: SANDOZ
- Status: approved
🇺🇸 Parlodel in United States
FDA authorised Parlodel on 13 January 1998
Marketing authorisations
FDA — authorised 2 April 1998
- Application: NDA017962
- Marketing authorisation holder: ESJAY PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2015
- Application: ANDA077226
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
FDA — authorised 3 April 2020
- Application: NDA020866
- Marketing authorisation holder: VEROSCIENCE
- Indication: Labeling
- Status: approved
FDA — authorised 21 August 2020
- Application: ANDA077646
- Marketing authorisation holder: PADAGIS US
- Indication: Labeling
- Status: approved
Parlodel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Parlodel approved in United States?
Yes. FDA authorised it on 13 January 1998; FDA authorised it on 2 April 1998; FDA authorised it on 13 February 2015.
Who is the marketing authorisation holder for Parlodel in United States?
SANDOZ holds the US marketing authorisation.