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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213714


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NDA 213714 describes ENALAPRIL MALEATE, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in twenty-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the ENALAPRIL MALEATE profile page.

The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 213714
Tradename:ENALAPRIL MALEATE
Applicant:Alkem Labs Ltd
Ingredient:enalapril maleate
Patents:0
Pharmacology for NDA: 213714
Medical Subject Heading (MeSH) Categories for 213714
Suppliers and Packaging for NDA: 213714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate SOLUTION;ORAL 213714 ANDA Ascend Laboratories, LLC 67877-712 67877-712-81 150 mL in 1 BOTTLE (67877-712-81)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Mar 30, 2022TE:ABRLD:No

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