FDA — authorised 17 August 1978
- Application: NDA018086
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Status: supplemented
🇺🇸 TIMOLOL MALEATE in United States
FDA authorised TIMOLOL MALEATE on 17 August 1978 · 5,951 US adverse-event reports
Marketing authorisations
FDA — authorised 5 November 1986
- Application: NDA019463
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: TIMOPTIC IN OCUDOSE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 April 1989
- Application: ANDA072550
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1989
- Application: ANDA072551
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1989
- Application: ANDA072552
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 1990
- Application: ANDA072668
- Marketing authorisation holder: MYLAN
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA072919
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA072918
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA072917
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1993
- Application: ANDA072649
- Marketing authorisation holder: TEVA
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1993
- Application: ANDA072648
- Marketing authorisation holder: TEVA
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1993
- Application: ANDA072650
- Marketing authorisation holder: TEVA
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1995
- Application: ANDA074262
- Marketing authorisation holder: SANDOZ
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 April 1995
- Application: ANDA074261
- Marketing authorisation holder: SANDOZ
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074667
- Marketing authorisation holder: FOUGERA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074668
- Marketing authorisation holder: FOUGERA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074515
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074516
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074746
- Marketing authorisation holder: PACIFIC PHARMA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 March 1997
- Application: ANDA074747
- Marketing authorisation holder: PACIFIC PHARMA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 September 2002
- Application: ANDA075163
- Marketing authorisation holder: HIKMA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 June 2004
- Application: NDA021516
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: ISTALOL
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 April 2008
- Application: ANDA077259
- Marketing authorisation holder: FDC LTD
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 November 2009
- Application: ANDA090604
- Marketing authorisation holder: SANDOZ
- Status: approved
FDA — authorised 17 April 2015
- Application: ANDA204936
- Marketing authorisation holder: APOTEX
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 July 2018
- Application: ANDA207630
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 2 May 2019
- Application: ANDA207556
- Marketing authorisation holder: RISING
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 2020
- Application: ANDA212291
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 October 2020
- Application: ANDA212942
- Marketing authorisation holder: ALEMBIC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2021
- Application: ANDA207629
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 13 December 2021
- Application: ANDA212592
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 September 2022
- Application: ANDA216596
- Marketing authorisation holder: MICRO LABS
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 September 2022
- Application: ANDA216533
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 September 2022
- Application: ANDA215733
- Marketing authorisation holder: DR REDDYS
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 4 October 2022
- Application: ANDA201949
- Marketing authorisation holder: REGCON HOLDINGS
- Indication: Not Applicable
- Status: approved
FDA — authorised 23 March 2023
- Application: ANDA213540
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 8 May 2023
- Application: ANDA217195
- Marketing authorisation holder: SENTISS PHARMA
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 26 May 2023
- Application: ANDA217343
- Marketing authorisation holder: MICRO LABS
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 16 May 2024
- Application: ANDA214987
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 23 May 2024
- Application: ANDA216343
- Marketing authorisation holder: AMNEAL
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 July 2024
- Application: ANDA217764
- Marketing authorisation holder: SOMERSET
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 July 2024
- Application: ANDA216653
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 August 2024
- Application: ANDA218460
- Marketing authorisation holder: CAPLIN
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 16 September 2024
- Application: ANDA210640
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA072271
- Marketing authorisation holder: WATSON LABS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072270
- Marketing authorisation holder: WATSON LABS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA204912
- Marketing authorisation holder: AKORN INC
- Local brand name: TIMOLOL MALEATE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA072269
- Marketing authorisation holder: WATSON LABS
- Local brand name: TIMOLOL MALEATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,951
Most-reported reactions
- Treatment Failure — 1,103 reports (18.53%)
- Drug Ineffective — 942 reports (15.83%)
- Eye Irritation — 634 reports (10.65%)
- Eye Pain — 605 reports (10.17%)
- Fatigue — 532 reports (8.94%)
- Off Label Use — 505 reports (8.49%)
- Vision Blurred — 426 reports (7.16%)
- Diarrhoea — 404 reports (6.79%)
- Ocular Hyperaemia — 401 reports (6.74%)
- Dizziness — 399 reports (6.7%)
TIMOLOL MALEATE 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 TIMOLOL MALEATE approved in United States?
Yes. FDA authorised it on 17 August 1978; FDA authorised it on 5 November 1986; FDA authorised it on 13 April 1989.
Who is the marketing authorisation holder for TIMOLOL MALEATE in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.