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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212894


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NDA 212894 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 212894
Tradename:ENALAPRIL MALEATE
Applicant:Amneal
Ingredient:enalapril maleate
Patents:0
Pharmacology for NDA: 212894
Medical Subject Heading (MeSH) Categories for 212894
Suppliers and Packaging for NDA: 212894
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate SOLUTION;ORAL 212894 ANDA Amneal Pharmaceuticals NY LLC 69238-1729 69238-1729-7 1 BOTTLE in 1 CARTON (69238-1729-7) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Jun 29, 2022TE:ABRLD:No

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