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Last Updated: April 28, 2024

Details for New Drug Application (NDA): 017963

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NDA 017963 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 017963

Tradename:	LOPRESSOR
Applicant:	Validus Pharms
Ingredient:	metoprolol tartrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017963

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 017963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963	NDA	Validus Pharmaceuticals LLC	30698-458	30698-458-01	100 TABLET in 1 BOTTLE (30698-458-01)
LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963	NDA	Validus Pharmaceuticals LLC	30698-459	30698-459-01	100 TABLET in 1 BOTTLE (30698-459-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017963

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Validus Pharms	LOPRESSOR	metoprolol tartrate	TABLET;ORAL	017963-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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