NDC 82584-604

COSOPT PF

Dorzolamide Hydrochloride And Timolol Maleate

COSOPT PF is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Thea Pharma Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

Product ID82584-604_ecff8715-7c6e-5c89-e053-2a95a90a7f18
NDC82584-604
Product TypeHuman Prescription Drug
Proprietary NameCOSOPT PF
Generic NameDorzolamide Hydrochloride And Timolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-12-10
Marketing CategoryNDA /
Application NumberNDA202667
Labeler NameThea Pharma Inc.
Substance NameDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active Ingredient Strength20 mg/mL; mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 82584-604-30

4 POUCH in 1 CARTON (82584-604-30) > 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) > .2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-12-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "COSOPT PF" or generic name "Dorzolamide Hydrochloride And Timolol Maleate"

NDCBrand NameGeneric Name
17478-604COSOPT PFDorzolamide Hydrochloride and Timolol Maleate
17478-605COSOPTDorzolamide Hydrochloride and Timolol Maleate
55545-1007Dorzolamide and TimololDorzolamide Hydrochloride and Timolol Maleate
17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
50090-2867Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
24208-486Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol Maleate
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