You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212639


✉ Email this page to a colleague

« Back to Dashboard


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 twelve 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
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 Limited 46708-519 46708-519-10 1 BOTTLE in 1 CARTON (46708-519-10) / 10 mL in 1 BOTTLE
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.