FDA — authorised 9 December 1974
- Application: ANDA061886
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Amoxil in United States
FDA authorised Amoxil on 9 December 1974
Marketing authorisations
FDA — authorised 10 December 1974
- Application: ANDA061885
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 August 1979
- Application: ANDA062216
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AMOXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 November 1979
- Application: ANDA062226
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AMOXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 October 1980
- Application: NDA050542
- Marketing authorisation holder: US ANTIBIOTICS
- Local brand name: AMOXIL
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 8 March 1988
- Application: ANDA062885
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 March 1992
- Application: ANDA063099
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 1996
- Application: ANDA064013
- Marketing authorisation holder: TEVA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 August 2000
- Application: ANDA064076
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 September 2006
- Application: ANDA065162
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 27 August 2010
- Application: NDA050785
- Marketing authorisation holder: US ANTIBIOTICS
- Indication: Labeling
- Status: approved
FDA — authorised 1 May 2024
- Application: ANDA205707
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Indication: Labeling
- Status: approved
The FDA approved Amoxil, manufactured by MICRO LABS LTD INDIA, for marketing in the United States on May 1, 2024. The approval was granted under the standard expedited pathway, with application number ANDA205707. The approved indication for Amoxil is listed in the labeling.
FDA
- Application: ANDA062152
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062154
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062099
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062098
- Marketing authorisation holder: APOTHECON
- Local brand name: TRIMOX
- Indication: CAPSULE — ORAL
- Status: approved
Amoxil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Amoxil approved in United States?
Yes. FDA authorised it on 9 December 1974; FDA authorised it on 10 December 1974; FDA authorised it on 2 August 1979.
Who is the marketing authorisation holder for Amoxil in United States?
APOTHECON holds the US marketing authorisation.