FDA — authorised 15 January 1975
- Application: ANDA083029
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 PROPANTHELINE BROMIDE in United States
FDA authorised PROPANTHELINE BROMIDE on 15 January 1975
Marketing authorisations
FDA — authorised 4 August 1976
- Application: ANDA080977
- Marketing authorisation holder: PVT FORM
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 1983
- Application: ANDA087663
- Marketing authorisation holder: ASCOT
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1988
- Application: ANDA088377
- Marketing authorisation holder: PAR PHARM
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085780
- Marketing authorisation holder: HEATHER
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083151
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA084541
- Marketing authorisation holder: IMPAX LABS
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083706
- Marketing authorisation holder: MYLAN
- Local brand name: PROPANTHELINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
PROPANTHELINE BROMIDE 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 PROPANTHELINE BROMIDE approved in United States?
Yes. FDA authorised it on 15 January 1975; FDA authorised it on 4 August 1976; FDA authorised it on 18 May 1983.
Who is the marketing authorisation holder for PROPANTHELINE BROMIDE in United States?
WATSON LABS holds the US marketing authorisation.