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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 018303


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NDA 018303 describes LOPRESSOR HCT, which is a drug marketed by Validus Pharms 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. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 018303
Tradename:LOPRESSOR HCT
Applicant:Validus Pharms
Ingredient:hydrochlorothiazide; metoprolol tartrate
Patents:0
Pharmacology for NDA: 018303
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 30698-461 30698-461-01 100 TABLET in 1 BOTTLE (30698-461-01)
LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303 NDA Validus Pharmaceuticals LLC 30698-462 30698-462-01 100 TABLET in 1 BOTTLE (30698-462-01)

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:DISCNDosage:TABLET;ORALStrength25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 31, 1984TE:RLD: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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Validus Pharms LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-002 Dec 31, 1984 ⤷  Try a Trial ⤷  Try a Trial
Validus Pharms LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-002 Dec 31, 1984 ⤷  Try a Trial ⤷  Try a Trial
Validus Pharms LOPRESSOR HCT hydrochlorothiazide; metoprolol tartrate TABLET;ORAL 018303-001 Dec 31, 1984 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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