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Last Updated: April 23, 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
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG TARTRATE
Approval Date:	Dec 27, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 200MG TARTRATE
Approval Date:	Dec 27, 1989	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 300MG TARTRATE
Approval Date:	Dec 27, 1989	TE:		RLD:	No

Expired US Patents for NDA 019786

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

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