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Last Updated: August 3, 2021

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Details for New Drug Application (NDA): 075496

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NDA 075496 describes ENALAPRIL MALEATE, which is a drug marketed by Apothecon, Beximco Pharms Usa, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Nostrum Labs Inc, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Watson Labs, Wockhardt Ltd, Cosette, Dr Reddys Labs Ltd, Taro Pharm Inds, and Upsher Smith Labs, and is included in twenty-three NDAs. It is available from twenty-seven 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. Five suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 075496
Applicant:Sandoz Inc
Ingredient:enalapril maleate
Formulation / Manufacturing:see details
Pharmacology for NDA: 075496
Medical Subject Heading (MeSH) Categories for 075496
Suppliers and Packaging for NDA: 075496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496 ANDA Northstar RxLLC 16714-442 16714-442-01 100 TABLET in 1 BOTTLE (16714-442-01)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496 ANDA Northstar RxLLC 16714-442 16714-442-02 1000 TABLET in 1 BOTTLE (16714-442-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 22, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2000TE:ABRLD:No

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