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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 019786


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NDA 019786 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 019786
Tradename:LOPRESSOR
Applicant:Novartis
Ingredient:metoprolol fumarate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Dec 27, 1989TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:Dec 27, 1989TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 300MG TARTRATE
Approval Date:Dec 27, 1989TE:RLD:No

Expired US Patents for NDA 019786

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LOPRESSOR metoprolol fumarate TABLET, EXTENDED RELEASE;ORAL 019786-004 Dec 27, 1989 ⤷  Sign Up ⤷  Sign Up
Novartis LOPRESSOR metoprolol fumarate TABLET, EXTENDED RELEASE;ORAL 019786-003 Dec 27, 1989 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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