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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 018704


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NDA 018704 describes LOPRESSOR, which is a drug marketed by Novartis and Validus Pharms and is included in four NDAs. It is available from one supplier. Additional details are available on the LOPRESSOR profile page.

The generic ingredient in LOPRESSOR 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 018704
Tradename:LOPRESSOR
Applicant:Novartis
Ingredient:metoprolol tartrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 30, 1984TE:RLD:Yes

Expired US Patents for NDA 018704

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LOPRESSOR metoprolol tartrate INJECTABLE;INJECTION 018704-001 Mar 30, 1984 ⤷  Try a Trial ⤷  Try a Trial
Novartis LOPRESSOR metoprolol tartrate INJECTABLE;INJECTION 018704-001 Mar 30, 1984 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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