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Last Updated: July 7, 2020

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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. Eight suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for 021770
Tradename:ALPHAGAN P
Ingredient:brimonidine tartrate
Pharmacology for NDA: 021770
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 021770
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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 19, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 10, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jan 10, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 18, 2022Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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