FDA — authorised 9 May 2013
- Application: NDA021902
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 SINECATECHINS in United States
FDA authorised SINECATECHINS on 9 May 2013
Marketing authorisation
SINECATECHINS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is SINECATECHINS approved in United States?
Yes. FDA authorised it on 9 May 2013.
Who is the marketing authorisation holder for SINECATECHINS in United States?
ANI PHARMS holds the US marketing authorisation.