Details for New Drug Application (NDA): 078480
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NDA 078480 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Lupin Ltd, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in twenty-six NDAs. It is available from twelve suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 078480
| Tradename: | BRIMONIDINE TARTRATE |
| Applicant: | Apotex |
| Ingredient: | brimonidine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 078480
| Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 078480
Suppliers and Packaging for NDA: 078480
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078480 | ANDA | Apotex Corp. | 60505-0577 | 60505-0577-1 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0577-1) / 5 mL in 1 BOTTLE, DROPPER |
| BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 078480 | ANDA | Apotex Corp. | 60505-0577 | 60505-0577-2 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0577-2) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | Dec 21, 2022 | TE: | AB | RLD: | No | ||||
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