Last Updated: May 3, 2026

Details for New Drug Application (NDA): 019851


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NDA 019851 describes LOTENSIN, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the LOTENSIN profile page.

The generic ingredient in LOTENSIN is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 019851
Tradename:LOTENSIN
Applicant:Validus Pharms
Ingredient:benazepril hydrochloride
Patents:0
Pharmacology for NDA: 019851
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectDecreased Blood Pressure
Suppliers and Packaging for NDA: 019851
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTENSIN benazepril hydrochloride TABLET;ORAL 019851 NDA Validus Pharmaceuticals LLC 30698-448 30698-448-01 100 TABLET in 1 BOTTLE (30698-448-01)
LOTENSIN benazepril hydrochloride TABLET;ORAL 019851 NDA Validus Pharmaceuticals LLC 30698-449 30698-449-01 100 TABLET in 1 BOTTLE (30698-449-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 25, 1991TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 25, 1991TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 25, 1991TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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