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Details for New Drug Application (NDA): 021398
NDA 021398 describes COMBIGAN, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COMBIGAN profile page.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
The generic ingredient in COMBIGAN is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 021398
| Tradename: | COMBIGAN |
| Applicant: | Allergan |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021398
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 021398
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398 | NDA | Allergan, Inc. | 0023-9211 | N | 0023-9211-03 |
| COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398 | NDA | Allergan, Inc. | 0023-9211 | N | 0023-9211-05 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2%;EQ 0.5% BASE | ||||
| Approval Date: | Oct 30, 2007 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Apr 19, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Apr 19, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE TWICE DAILY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jan 19, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
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