Details for New Drug Application (NDA): 021398
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NDA 021398 describes COMBIGAN, which is a drug marketed by Abbvie and is included in one NDA. It is available from three suppliers. 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 021398
| Tradename: | COMBIGAN |
| Applicant: | Abbvie |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 0 |
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 | 0023-9211-03 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-03) / 2.5 mL in 1 BOTTLE, DROPPER |
| COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398 | NDA | Allergan, Inc. | 0023-9211 | 0023-9211-05 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9211-05) / 5 mL in 1 BOTTLE, DROPPER |
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: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021398
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Abbvie | COMBIGAN | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 021398-001 | Oct 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
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