➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
McKinsey
Moodys
Baxter
Johnson and Johnson

Last Updated: August 3, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075496


Email this page to a colleague

« Back to Dashboard

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
Tradename:ENALAPRIL MALEATE
Applicant:Sandoz Inc
Ingredient:enalapril maleate
Patents:0
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
McKesson
Merck
Colorcon
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.