Active ingredient
Timolol
77 finished FDA listings contain Timolol as their only active ingredient; 43 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TIMOLOL, TIMOLOL ANHYDROUS, TIMOLOL MALEATE
- Dosage forms
- Solution, Solution, Gel Forming / Drops, Solution/ Drops, Tablet
- Routes
- Ophthalmic, Oral
- Manufacturers / labelers
- 25
- Strengths listed
- 10 mg/1 · 2.5 mg/ml · 2.56 mg/ml · 20 mg/1 · 3.4 mg/ml · 5 mg/1 · 5 mg/ml · 5.12 mg/ml · 6.8 mg/ml
- Brand names in FDA listings
- Betimol, Istalol, Timolol Gfs, Timolol Maleate, Timolol Maleate Ophthalmic Gel Forming Solution, Timoptic, Timoptic In Ocudose, Timoptic-Xe
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10600
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018086 | BAUSCH AND LOMB INC | 1978-08-17 | 4 |
| NDA 019463 | BAUSCH AND LOMB INC | 1986-11-05 | 3 |
| ANDA 072668 | MYLAN | 1990-06-08 | 1 |
| NDA 020330 | BAUSCH AND LOMB INC | 1993-11-04 | 4 |
| NDA 020439 | THEA PHARMA | 1995-03-31 | 2 |
| ANDA 074262 | SANDOZ | 1995-04-28 | 2 |
| ANDA 074261 | SANDOZ | 1995-04-28 | 1 |
| ANDA 074747 | ABBVIE | 1997-03-25 | 2 |
| ANDA 074746 | ABBVIE | 1997-03-25 | 1 |
| NDA 020963 | SANDOZ | 1998-10-21 | 2 |
| NDA 021516 | BAUSCH AND LOMB | 2004-06-04 | 2 |
| ANDA 077259 | FDC LTD | 2008-04-30 | 3 |
| ANDA 078771 | MANKIND PHARMA | 2009-09-28 | 7 |
| ANDA 207556 | RISING | 2019-05-02 | 3 |
| ANDA 212942 | ALEMBIC | 2020-10-22 | 4 |
| ANDA 212592 | J MOLNER | 2021-12-13 | 1 |
| ANDA 214645 | GLAND | 2022-06-24 | 6 |
| ANDA 216596 | MICRO LABS | 2022-09-07 | 1 |
| ANDA 216533 | INGENUS PHARMS LLC | 2022-09-13 | 2 |
| ANDA 215733 | DR REDDYS | 2022-09-22 | 4 |
| ANDA 213540 | EUGIA PHARMA | 2023-03-23 | 1 |
| ANDA 217195 | SENTISS PHARMA | 2023-05-08 | 1 |
| ANDA 217343 | MICRO LABS | 2023-05-26 | 2 |
| ANDA 217764 | SOMERSET | 2024-07-03 | 6 |
| ANDA 216653 | SOMERSET THERAPS LLC | 2024-07-03 | 2 |
| ANDA 218460 | CAPLIN | 2024-08-07 | 5 |
| ANDA 210640 | SOMERSET THERAPS LLC | 2024-09-16 | 2 |
| ANDA 216654 | SOMERSET | 2024-10-10 | 3 |
Official labeling on DailyMed
- TIMOLOL MALEATE SOLUTION/ DROPS [RISING PHARMA HOLDINGS, INC.] · version 11 · 2026-09-07
- TIMOLOL MALEATE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] · version 20 · 2026-09-03
- TIMOPTIC IN OCUDOSE (TIMOLOL MALEATE) SOLUTION [NORDIC PHARMA, INC.] · version 7 · 2026-08-10
- TIMOLOL MALEATE SOLUTION [SANDOZ INC] · version 10 · 2026-08-04
- TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] · version 16 · 2026-05-25
- TIMOLOL MALEATE SOLUTION, GEL FORMING / DROPS [SAGENT PHARMACEUTICALS] · version 1 · 2026-01-16
- TIMOLOL MALEATE SOLUTION [A-S MEDICATION SOLUTIONS] · version 1 · 2025-12-31
- TIMOLOL MALEATE SOLUTION [ARMAS PHARMACEUTICALS, INC.] · version 3 · 2025-12-05
- TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION SOLUTION, GEL FORMING / DROPS [FOSUN PHARMA USA INC] · version 6 · 2025-09-29
- BETIMOL (TIMOLOL) SOLUTION/ DROPS [THEA PHARMA INC.] · version 6 · 2025-06-30
- TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.] · version 10 · 2025-05-22
- TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2025-04-28
Showing the 12 most recent of 41 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.