Details for New Drug Application (NDA): 021262

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NDA 021262 describes ALPHAGAN P, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. There is one patent 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. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for 021262

Tradename:	ALPHAGAN P
Applicant:	Abbvie
Ingredient:	brimonidine tartrate
Patents:	0

Pharmacology for NDA: 021262

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 021262

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 021262

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262	NDA	Allergan, Inc.	0023-9177	0023-9177-05	1 BOTTLE, DROPPER in 1 CARTON (0023-9177-05) / 5 mL in 1 BOTTLE, DROPPER
ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262	NDA	Allergan, Inc.	0023-9177	0023-9177-10	1 BOTTLE, DROPPER in 1 CARTON (0023-9177-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.15%
Approval Date:	Mar 16, 2001	TE:	AT	RLD:	Yes

Expired US Patents for NDA 021262

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	9,295,641*PED	⤷ Subscribe
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,465,464*PED	⤷ Subscribe
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,673,337*PED	⤷ Subscribe
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	5,424,078*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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