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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.

ApplicationSponsorOriginal approvalListings
NDA 018086BAUSCH AND LOMB INC1978-08-174
NDA 019463BAUSCH AND LOMB INC1986-11-053
ANDA 072668MYLAN1990-06-081
NDA 020330BAUSCH AND LOMB INC1993-11-044
NDA 020439THEA PHARMA1995-03-312
ANDA 074262SANDOZ1995-04-282
ANDA 074261SANDOZ1995-04-281
ANDA 074747ABBVIE1997-03-252
ANDA 074746ABBVIE1997-03-251
NDA 020963SANDOZ1998-10-212
NDA 021516BAUSCH AND LOMB2004-06-042
ANDA 077259FDC LTD2008-04-303
ANDA 078771MANKIND PHARMA2009-09-287
ANDA 207556RISING2019-05-023
ANDA 212942ALEMBIC2020-10-224
ANDA 212592J MOLNER2021-12-131
ANDA 214645GLAND2022-06-246
ANDA 216596MICRO LABS2022-09-071
ANDA 216533INGENUS PHARMS LLC2022-09-132
ANDA 215733DR REDDYS2022-09-224
ANDA 213540EUGIA PHARMA2023-03-231
ANDA 217195SENTISS PHARMA2023-05-081
ANDA 217343MICRO LABS2023-05-262
ANDA 217764SOMERSET2024-07-036
ANDA 216653SOMERSET THERAPS LLC2024-07-032
ANDA 218460CAPLIN2024-08-075
ANDA 210640SOMERSET THERAPS LLC2024-09-162
ANDA 216654SOMERSET2024-10-103

Official labeling on DailyMed

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.