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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Federal Trade Commission
Queensland Health
McKinsey
QuintilesIMS
Medtronic
Cerilliant
Moodys

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020033

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NDA 020033 describes LOTENSIN HCT, which is a drug marketed by Us Pharms Holdings I and is included in one NDA. It is available from three suppliers. Additional details are available on the LOTENSIN HCT profile page.

The generic ingredient in LOTENSIN HCT 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 020033
Tradename:LOTENSIN HCT
Applicant:Us Pharms Holdings I
Ingredient:benazepril hydrochloride; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020033
Suppliers and Packaging for NDA: 020033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033 NDA Validus Pharmaceuticals LLC 30698-452 N 30698-452-01
LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033 NDA Validus Pharmaceuticals LLC 30698-453 N 30698-453-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 19, 1992TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:May 19, 1992TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;25MG
Approval Date:May 19, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020033

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033-003 May 19, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033-001 May 19, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033-004 May 19, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOTENSIN HCT benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 020033-002 May 19, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
McKesson
Dow
Fuji
Teva
Argus Health
Medtronic
Mallinckrodt
Cantor Fitzgerald

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