FDA — authorised 13 January 2017
- Application: ANDA091528
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Labeling
- Status: approved
🇺🇸 Homatropin in United States
FDA authorised Homatropin on 13 January 2017
Marketing authorisations
FDA — authorised 13 February 2017
- Application: ANDA203535
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
FDA — authorised 21 February 2017
- Application: ANDA207487
- Marketing authorisation holder: ABHAI LLC
- Status: approved
FDA — authorised 28 June 2018
- Application: NDA005213
- Marketing authorisation holder: GENUS
- Indication: Labeling
- Status: approved
FDA — authorised 5 July 2018
- Application: ANDA207176
- Marketing authorisation holder: AVANTHI INC
- Indication: Labeling
- Status: approved
FDA
- Status: approved
Homatropin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Homatropin approved in United States?
Yes. FDA authorised it on 13 January 2017; FDA authorised it on 13 February 2017; FDA authorised it on 21 February 2017.
Who is the marketing authorisation holder for Homatropin in United States?
NOVEL LABS INC holds the US marketing authorisation.