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Details for New Drug Application (NDA): 021770
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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
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
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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