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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213273


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NDA 213273 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 213273
Tradename:ENALAPRIL MALEATE
Applicant:Prinston Inc
Ingredient:enalapril maleate
Patents:0
Pharmacology for NDA: 213273
Medical Subject Heading (MeSH) Categories for 213273
Suppliers and Packaging for NDA: 213273
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 213273 ANDA Solco Healthcare US, LLC 43547-545 43547-545-03 30 TABLET in 1 BOTTLE (43547-545-03)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 213273 ANDA Solco Healthcare US, LLC 43547-545 43547-545-09 90 TABLET in 1 BOTTLE (43547-545-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jul 7, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 7, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 7, 2022TE:ABRLD:No

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