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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 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.
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 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
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 |
Paragraph IV (Patent) Challenges for 021262
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ALPHAGAN P | SOLUTION/DROPS;OPHTHALMIC | brimonidine tartrate | 021262 | 2006-11-03 |
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: | 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 | ||
| Patent: | Start Trial | Patent Expiration: | Jan 28, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021262
| 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 | Start Trial | Start Trial |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
| Allergan | ALPHAGAN P | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 021262-001 | Mar 16, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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