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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214467


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NDA 214467 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, Unique Pharm, Watson Labs, Wockhardt Ltd, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty 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 214467
Tradename:ENALAPRIL MALEATE
Applicant:Annora Pharma
Ingredient:enalapril maleate
Patents:0
Pharmacology for NDA: 214467
Medical Subject Heading (MeSH) Categories for 214467
Suppliers and Packaging for NDA: 214467
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate SOLUTION;ORAL 214467 ANDA Camber Pharmaceuticals, Inc. 31722-020 31722-020-15 1 BOTTLE in 1 CARTON (31722-020-15) / 150 mL in 1 BOTTLE
ENALAPRIL MALEATE enalapril maleate SOLUTION;ORAL 214467 ANDA NorthStar RxLLC 72603-247 72603-247-01 1 BOTTLE in 1 CARTON (72603-247-01) / 150 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Feb 24, 2022TE:ABRLD:No

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