FDA — authorised 28 October 2008
- Application: ANDA077847
- Marketing authorisation holder: HIKMA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 DORZOLAMIDE HYDROCHLORIDE in United States
FDA authorised DORZOLAMIDE HYDROCHLORIDE on 28 October 2008
Marketing authorisations
FDA — authorised 28 October 2008
- Application: ANDA077846
- Marketing authorisation holder: HIKMA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 October 2008
- Application: ANDA078395
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 6 November 2008
- Application: ANDA078748
- Marketing authorisation holder: SANDOZ
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 6 November 2008
- Application: ANDA078749
- Marketing authorisation holder: SANDOZ
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 December 2008
- Application: ANDA078756
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 April 2009
- Application: ANDA078981
- Marketing authorisation holder: SANDOZ
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 June 2009
- Application: ANDA090143
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 September 2009
- Application: ANDA078704
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA090604
- Marketing authorisation holder: SANDOZ
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA079186
- Marketing authorisation holder: AM REGENT
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 December 2013
- Application: ANDA091034
- Marketing authorisation holder: ZAMBON SPA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 December 2013
- Application: ANDA091180
- Marketing authorisation holder: ZAMBON SPA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 September 2014
- Application: ANDA203058
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 December 2014
- Application: ANDA201998
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 July 2018
- Application: ANDA207630
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 January 2019
- Application: ANDA205294
- Marketing authorisation holder: FDC LTD
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 June 2019
- Application: ANDA205295
- Marketing authorisation holder: FDC LTD
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 June 2019
- Application: ANDA207523
- Marketing authorisation holder: SOMERSET
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 August 2019
- Application: ANDA212639
- Marketing authorisation holder: ALEMBIC
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 November 2019
- Application: ANDA204778
- Marketing authorisation holder: MICRO LABS
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 May 2020
- Application: ANDA204777
- Marketing authorisation holder: MICRO LABS
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 May 2021
- Application: ANDA213099
- Marketing authorisation holder: ALEMBIC
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2021
- Application: ANDA207629
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA215660
- Marketing authorisation holder: GLAND
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA215004
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: DORZOLAMIDE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 February 2025
- Application: ANDA216308
- Marketing authorisation holder: NEW HEIGHTSRX
- Local brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
Frequently asked questions
Is DORZOLAMIDE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 28 October 2008; FDA authorised it on 28 October 2008; FDA authorised it on 28 October 2008.
Who is the marketing authorisation holder for DORZOLAMIDE HYDROCHLORIDE in United States?
HIKMA holds the US marketing authorisation.