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Last Updated: June 19, 2021

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Details for New Drug Application (NDA): 205294

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NDA 205294 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Akorn, Alembic Pharms Ltd, Am Regent, Bausch And Lomb, Fdc Ltd, Indoco, Micro Labs, Rubicon, Sandoz Inc, Teva Pharms, Zambon Spa, Aurobindo Pharma Ltd, Lannett Co Inc, Sandoz, and Somerset, and is included in twenty-six NDAs. It is available from nine suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 205294
Applicant:Fdc Ltd
Ingredient:dorzolamide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 205294
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 205294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 205294 ANDA Leading Pharma, LLC 69315-304 69315-304-05 1 BOTTLE in 1 CARTON (69315-304-05) > 5 mL in 1 BOTTLE
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 205294 ANDA Leading Pharma, LLC 69315-304 69315-304-10 1 BOTTLE in 1 CARTON (69315-304-10) > 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Jan 24, 2019TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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