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Last Updated: August 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204778


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NDA 204778 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-eight 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 204778
Tradename:DORZOLAMIDE HYDROCHLORIDE
Applicant:Micro Labs
Ingredient:dorzolamide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204778
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 204778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 204778 ANDA Micro Labs Limited 42571-141 42571-141-26 1 BOTTLE in 1 CARTON (42571-141-26) > 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Nov 8, 2019TE:ATRLD:No

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