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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Queensland Health
Baxter
Cipla
Julphar
US Department of Justice
Dow
Medtronic
Harvard Business School

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018303

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NDA 018303 describes LOPRESSOR HCT, which is a drug marketed by Us Pharms Holdings I and is included in one NDA. It is available from one supplier. Additional details are available on the LOPRESSOR HCT profile page.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 018303
Tradename:LOPRESSOR HCT
Applicant:Us Pharms Holdings I
Ingredient:hydrochlorothiazide; metoprolol tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018303
Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 018303
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303 NDA Validus Pharmaceuticals LLC 30698-460 E 30698-460-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;50MG
Approval Date:Dec 31, 1984TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Dec 31, 1984TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 31, 1984TE:RLD:Yes

Expired US Patents for NDA 018303

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharms Holdings I LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-002 Dec 31, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-001 Dec 31, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-003 Dec 31, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Us Pharms Holdings I LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-003 Dec 31, 1984 ➤ 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:

McKinsey
UBS
Citi
Boehringer Ingelheim
Federal Trade Commission
Johnson and Johnson
Argus Health
Cipla
Accenture

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