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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 212639


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NDA 212639 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-two NDAs. It is available from eleven 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. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 212639
Tradename:DORZOLAMIDE HYDROCHLORIDE
Applicant:Alembic
Ingredient:dorzolamide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212639
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 212639
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 212639 ANDA Alembic Pharmaceuticals Inc. 62332-519 62332-519-10 1 BOTTLE in 1 CARTON (62332-519-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Aug 9, 2019TE:ATRLD:No

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