Details for New Drug Application (NDA): 020816

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NDA 020816 describes AZOPT, which is a drug marketed by Sandoz and is included in one NDA. It is available from three suppliers. Additional details are available on the AZOPT profile page.

The generic ingredient in AZOPT is brinzolamide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the brinzolamide profile page.

Summary for 020816

Tradename:	AZOPT
Applicant:	Sandoz
Ingredient:	brinzolamide
Patents:	0

Pharmacology for NDA: 020816

Mechanism of Action	Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 020816

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816	NDA	Novartis Pharmaceuticals Corporation	0078-0722	0078-0722-10	1 BOTTLE in 1 CARTON (0078-0722-10) / 10 mL in 1 BOTTLE
AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816	NDA	Novartis Pharmaceuticals Corporation	0078-0722	0078-0722-15	1 BOTTLE in 1 CARTON (0078-0722-15) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Apr 1, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020816

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	⤷ Subscribe	⤷ Subscribe
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	⤷ Subscribe	⤷ Subscribe
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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