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 | Betimol (timolol ophthalmic solution), Santen, Labeling Revision

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