Details for New Drug Application (NDA): 216772
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NDA 216772 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb Inc, Dr Reddys Labs Sa, Gland, Lupin, Mankind Pharma, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Amneal, Caplin, Glenmark Pharms Ltd, Saba Ilac Sanayive, Sentiss, and Somerset, and is included in thirty-four NDAs. It is available from fourteen suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are two drug master file entries for this compound. Fifteen 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 two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 216772
| Tradename: | BRIMONIDINE TARTRATE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | brimonidine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 216772
| Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 216772
Suppliers and Packaging for NDA: 216772
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 216772 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1420 | 0832-1420-05 | 1 BOTTLE, DROPPER in 1 CARTON (0832-1420-05) / 5 mL in 1 BOTTLE, DROPPER |
| BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 216772 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1420 | 0832-1420-10 | 1 BOTTLE, DROPPER in 1 CARTON (0832-1420-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.15% | ||||
| Approval Date: | Jun 12, 2024 | TE: | RLD: | No | |||||
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