Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Blocadren (Timolol Maleate) Tablets, Merck & Co., NDA 18-017/S-037 3/27/02 4/8/02 5/30/02 Blocadren (Timolol Maleate) Tablets, 5mg, 10mg & 20mg, Merck & Co., NDA 18-017/S-036 Timolide Maleate (timolol maleate) Gel Forming Solution, 0.25 & 0.5%, Falcon NDA 20-963/S7 7/2/03 Timolide (timolol maleate-hydrochlorothiazide) Tablets, 10/25 mg, Merck & Co., NDA 18-061/S-029 3/4/03 3/10/03 Timolol Maleate Ophthalmic Solution USP, 0.5% (base), Novex Pharma ANDA 75-412 9/8/00 10/30/00 12/17/01 Timolol Maleate Ophthalmic Solution USP, 0.25% (base), Novex Pharma ANDA 75-411 9/8/00 10/30/00 8/6/03 Timolol Maleate Ophthalmic Solution USP, 0.5% (base), Hi-Tech Pharmacal Co., ANDA 75-163 9/10/02 Timolol Maleate (timolol maleate) Ophthalmic Gel Forming Solution, Falcon Ltd. NDA 20-963/S7 7/2/03 7/8/03 7/8/03 Timolol GFS (timolol maleate ophthalmic gel forming solution, 0.25% and 0.5%), Falcon Pharmaceutical NDA 20-963/S-5 2/5/01 04/25/03 Timolol Indication: For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma Timolol Maleate (timolol maleate) ophthalmic gel forming solution, 0.25% and 0.5%, Alcon NDA 20-963 10/21/98 1/6/99 1/6/99 5/22/03 Timoptic (timolol maleate) ophthalmic solution, 0.25% and 0.5%, Merck & Co., NDA 18-086/S-058 4/29/02 5/2/02 5/1/02 Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution, 0.25% and 0.5% Merck & Co., NDA 18-086/S-054 4/12/01 12/11/02 05/08/03 Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution, 0.25% and 0.5% Merck & Co., NDA 18-086/S-052 3/18/98 9/11/03 Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution, 0.25% and 0.5% Merck & Co., NDA 19-463/S-022 4/15/03 Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution, 0.25% and 0.5% Merck & Co., NDA 19-463/S-019 3/18/98 9/11/03 Timoptic XE (timolol maleate) Merck & Co., 20-330/S11 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE Solution/Drops; Ophthalmic 2% BASE;EQ 0.5% BASE COSOPT MERCK 018061 HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE Tablet; 25MG;10MG TIMOLIDE 10-25 MERCK 020439 TIMOLOL Solution/Drops; Ophthalmic 0.25% BASE BETIMOL SANTEN OY 020439 TIMOLOL Solution/Drops; Ophthalmic 0.5% BASE BETIMOL SANTEN OY 020963 TIMOLOL MALEATE Solution, Gel Forming/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE FALCON 020963 TIMOLOL MALEATE Solution, Gel Forming/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE FALCON 020330 TIMOLOL MALEATE Solution, Gel Forming/Drops; Ophthalmic 0.25% BASE TIMOPTIC-XE MERCK 020330 TIMOLOL MALEATE Solution, Gel Forming/Drops; Ophthalmic 0.5% BASE TIMOPTIC-XE MERCK 074465 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE Akorn 074515 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE Akorn 074466 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE Akorn 074516 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE Akorn 074778 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE BAUSCH AND LOMB 074776 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE BAUSCH AND LOMB 074667 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE FOUGERA 074668 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE FOUGERA 018086 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOPTIC MERCK 019463 TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOPTIC IN OCUDOSE MERCK 019463 TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOPTIC IN OCUDOSE MERCK 018086 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOPTIC MERCK 075411 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE Novex 075412 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE Novex 074746 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.25% BASE TIMOLOL MALEATE PACIFIC 074747 AT TIMOLOL MALEATE Solution/Drops; Ophthalmic 0.5% BASE TIMOLOL MALEATE PACIFIC 075163 AT TIMOLOL MALEATE Solution; Ophthalmic 0.5% BASE TIMOLOL MALEATE HI TECH 072551 TIMOLOL MALEATE Tablet; 10MG TIMOLOL MALEATE Geneva 072552 TIMOLOL MALEATE Tablet; 20MG TIMOLOL MALEATE Geneva 072550 TIMOLOL MALEATE Tablet; 5MG TIMOLOL MALEATE Geneva 018017 TIMOLOL MALEATE Tablet; 10MG BLOCADREN MERCK 018017 TIMOLOL MALEATE Tablet; 20MG BLOCADREN MERCK 018017 TIMOLOL MALEATE Tablet; 5MG BLOCADREN MERCK 072667 TIMOLOL MALEATE Tablet; 10MG TIMOLOL MALEATE Mylan 072668 TIMOLOL MALEATE Tablet; 20MG TIMOLOL MALEATE Mylan 072666 TIMOLOL MALEATE Tablet; 5MG TIMOLOL MALEATE Mylan 072918 TIMOLOL MALEATE Tablet; 10MG TIMOLOL MALEATE Watson 072919 TIMOLOL MALEATE Tablet; 20MG TIMOLOL MALEATE Watson 072917 TIMOLOL MALEATE Tablet; 5MG TIMOLOL MALEATE Watson Timoptic (timolol maleate ophthalmic solution) Sterile Ophthalmic Solution, Merck & Co., Inc. Timoptic XE (timolol maleate) Ophthalmic Gel forming Solution, Merck & Co., Inc. Timoptic XE (timolol maleate ophthalmic gel forming solution), Merck & Co., Manufacturing Change or Addition & Labeling Revision   For the latest approval information, locate this drug using this index.