Details for New Drug Application (NDA): 020869

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NDA 020869 describes COSOPT, which is a drug marketed by Thea Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the COSOPT profile page.

The generic ingredient in COSOPT 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 020869

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

Pharmacology for NDA: 020869

Mechanism of Action	Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 020869

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869	NDA	Thea Pharma Inc.	82584-605	82584-605-10	1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE;EQ 0.5% BASE
Approval Date:	Apr 7, 1998	TE:	AT1	RLD:	Yes

Expired US Patents for NDA 020869

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	⤷ Sign Up	⤷ Sign Up
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	⤷ Sign Up	⤷ Sign Up
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	⤷ Sign Up	⤷ Sign Up
Thea Pharma	COSOPT	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	020869-001	Apr 7, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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