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Generated: April 24, 2019

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Details for New Drug Application (NDA): 019851

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NDA 019851 describes LOTENSIN, which is a drug marketed by Us Pharms Holdings I 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. Eleven suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 019851
Tradename:LOTENSIN
Applicant:Us Pharms Holdings I
Ingredient:benazepril hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019851
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:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 25, 1991TE:ABRLD: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

Expired US Patents for NDA 019851

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-003 Jun 25, 1991 ➤ Sign Up ➤ Sign Up
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-004 Jun 25, 1991 ➤ Sign Up ➤ Sign Up
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-001 Jun 25, 1991 ➤ Sign Up ➤ Sign Up
Us Pharms Holdings I LOTENSIN benazepril hydrochloride TABLET;ORAL 019851-002 Jun 25, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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