Details for New Drug Application (NDA): 216308
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NDA 216308 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Alembic Therap, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Hikma, Ingenus Pharms Llc, Micro Labs, Regcon Holdings, Rubicon Research, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE profile page.
The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is dorzolamide hydrochloride; timolol maleate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE is dorzolamide hydrochloride; timolol maleate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 216308
| Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Applicant: | Alembic Therap |
| Ingredient: | dorzolamide hydrochloride; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 216308
| Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
| Approval Date: | Feb 18, 2025 | TE: | AT2 | RLD: | No | ||||
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