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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219373

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NDA 219373 describes LOPRESSOR, which is a drug marketed by Novartis, Rubicon Research, Validus Pharms, and Xtm Consulting, and is included in six NDAs. It is available from two suppliers. 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. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for 219373

Tradename:	LOPRESSOR
Applicant:	Rubicon Research
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 219373

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 219373

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOPRESSOR	metoprolol tartrate	SOLUTION;ORAL	219373	NDA	VALIDUS PHARMACEUTICALS LLC	30698-464	30698-464-30	1 BOTTLE in 1 CARTON (30698-464-30) / 300 mL in 1 BOTTLE
LOPRESSOR	metoprolol tartrate	SOLUTION;ORAL	219373	NDA	VALIDUS PHARMACEUTICALS LLC	30698-464	30698-464-31	1 BOTTLE in 1 CARTON (30698-464-31) / 300 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Apr 10, 2025	TE:		RLD:	Yes

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