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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 074453

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NDA 074453 describes METOPROLOL TARTRATE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Sandoz, Steriscience Speclts, Watson Labs, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Norvium Bioscience, Purepac Pharm, Renata, Rubicon, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Youngtech Pharms Inc, Zydus Pharms, Alembic, and Sun Pharm Inds, and is included in thirty-six NDAs. It is available from fifty-five suppliers. Additional details are available on the METOPROLOL TARTRATE profile page.

The generic ingredient in METOPROLOL TARTRATE 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 074453

Tradename:	METOPROLOL TARTRATE
Applicant:	Renata
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 074453

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 074453

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074453	ANDA	Westminster Pharmaceuticals, LLC	69367-354	69367-354-01	100 TABLET in 1 BOTTLE (69367-354-01)
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074453	ANDA	Westminster Pharmaceuticals, LLC	69367-354	69367-354-10	1000 TABLET in 1 BOTTLE (69367-354-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 27, 1995	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 27, 1995	TE:	AB	RLD:	No

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