Details for New Drug Application (NDA): 021770

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NDA 021770 describes ALPHAGAN P, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ALPHAGAN P profile page.

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for 021770

Tradename:	ALPHAGAN P
Applicant:	Allergan
Ingredient:	brimonidine tartrate
Patents:	8

Pharmacology for NDA: 021770

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 021770

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 021770

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770	NDA	Allergan, Inc.	0023-9321	0023-9321-03	1 BOTTLE, DROPPER in 1 CARTON (0023-9321-03) > 3 mL in 1 BOTTLE, DROPPER
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770	NDA	Allergan, Inc.	0023-9321	0023-9321-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9321-05) > 5 mL in 1 BOTTLE, DROPPER

Paragraph IV (Patent) Challenges for 021770

Tradename	Dosage	Ingredient	NDA	Submissiondate
ALPHAGAN P	SOLUTION/DROPS;OPHTHALMIC	brimonidine tartrate	021770	2006-12-20

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	Aug 19, 2005	TE:		RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Jul 10, 2021	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Jan 10, 2022	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	Start Trial	Patent Expiration:	Jan 18, 2022	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021770

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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