Details for New Drug Application (NDA): 202667

NDA 202667 describes COSOPT PF, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the COSOPT PF profile page.

The generic ingredient in COSOPT PF is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 202667

Tradename:	COSOPT PF
Applicant:	Thea Pharma
Ingredient:	dorzolamide hydrochloride; timolol maleate
Patents:	0

Pharmacology for NDA: 202667

Mechanism of Action

Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 202667

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COSOPT PF	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202667	NDA	Akorn	50383-261	50383-261-61	4 POUCH in 1 CARTON (50383-261-61) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE
COSOPT PF	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	202667	NDA	Thea Pharma Inc.	82584-604	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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE;EQ 0.5% BASE
Approval Date:	Feb 1, 2012	TE:	AT2	RLD:	Yes

Complete Access Available with Subscription