Details for New Drug Application (NDA): 205295
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NDA 205295 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Ingenus Pharms Llc, Micro Labs, Rubicon, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in nineteen NDAs. It is available from sixteen 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 are fifteen drug master file entries for this compound. Eighteen 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 are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 205295
| Tradename: | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Applicant: | Fdc Ltd |
| Ingredient: | dorzolamide hydrochloride; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 205295
| Mechanism of Action | Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 205295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 205295 | ANDA | Leading Pharma, LLC | 69315-305 | 69315-305-05 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 205295 | ANDA | Leading Pharma, LLC | 69315-305 | 69315-305-10 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 2% BASE;EQ 0.5% BASE | ||||
| Approval Date: | Jun 13, 2019 | TE: | AT1 | RLD: | No | ||||
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