Details for New Drug Application (NDA): 021262

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

Summary for 021262

Tradename:	ALPHAGAN P
Applicant:	Allergan
Ingredient:	brimonidine tartrate
Patents:	5

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
Patent:	See Plans and Pricing	Patent Expiration:	Jan 10, 2022	Product Flag?		Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Jan 18, 2022	Product Flag?		Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Jan 28, 2022	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 021262

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	See Plans and Pricing	See Plans and Pricing
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	See Plans and Pricing	See Plans and Pricing
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	See Plans and Pricing	See Plans and Pricing
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	See Plans and Pricing	See Plans and Pricing
Allergan	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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