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DORZOLAMIDE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Cosopt (Dorzolamide/Timolol Solution), Merck NDA 20-869/S12 4/23/02 5/2/02 4/26/02 Cosopt/dorzolamide HCl and timolol maleate ophthalmic solution Merck NDA 20-869/S1 1/4/99 7/3/01 Cosopt/dorzolamide HCl and timolol maleate ophthalmic solution Merck NDA 20-869 Trusopt (dorzolamide hydrochloride ophthalmic solution), 2% Merck & Co., NDA 20-408/S-025 4/9/02 4/16/02 4/9/02 Trusopt (dorzolamide hydrochloride ophthalmic solution), 2 % Merck & Co., NDA 20-408/S-023 | Cosopt (dorzolamide hydrochloride-timolol maleate) ophthalmic solution, Merck & Co., Labeling Revision | COSOPT (dorzolamide hydrochloride-timolol maleate ophthalmic solution), Merck & Co., Labeling Revision | COSOPT (dorzolomide hydrochloride-timolol maleate), Merck & Co., Labeling Revision | COSOPT (dorzolamide hydrochloride-timolol maleate ophthalmic solution), Merck, Labeling Revision | Cosopt (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution, Merck & Co., Inc., Labeling Revision | Trusopt (dorzolamide hydrochloride) Ophthalmic Solution, Merck & Co., Inc., Labeling Revision | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Apotex Corp., Approval | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Hi-Tech Pharmacal Co., Inc., Approval | Dorzolamide Hydrochloride Ophthalmic Solution, Sandoz Canada Inc., Approval | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Sandoz Canada Inc., Approval | Dorzolamide Hydrochloride, Ophthalmic Solution, TEVA Parenteral Medicines, Inc., Approval | Dorzolamide Hydrochloride Ophthalmic Solution, Alcon, Inc., Approval | Dorzolamide Hydrochloride Ophthalmic Solution, Bausch & Lomb, Inc., Approval | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Bausch & Lomb, Inc., Approval | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Teva Parenteral, Approval | Dorzolamide Hydrochloride Ophthalmic Solution, PharmaForce, Inc., Approval | Dorzolamide Hydrochloride and Timolol Mealeate Ophthalmic Solution, Alcon Research, Ltd., Approval | COSOPT (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution, Merck & Co, Inc., Labeling Revision | TRUSOPT (dorzolamide hydrochloride) Ophthalmic Solution, Merck & Co, Inc., Labeling Revision | Cosopt Pf, dorzolamide hydrochloride; timolol maleate, Solution/Drops; Ophthalmic, Merck Sharp Dohme, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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