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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 074644

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NDA 074644 describes METOPROLOL TARTRATE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Onesource Specialty, Sandoz, Watson Labs, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Pharmobedient, Purepac Pharm, Renata, Rubicon Research, Sciegen Pharms Inc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Zydus Pharms, Alembic, Senores Pharms, and Sun Pharm Inds, and is included in thirty-seven NDAs. It is available from fifty 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. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for 074644

Tradename:	METOPROLOL TARTRATE
Applicant:	Sun Pharm Inds Inc
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 074644

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 074644

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074644	ANDA	A-S Medication Solutions	50090-0488	50090-0488-0	30 TABLET in 1 BOTTLE (50090-0488-0)
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	074644	ANDA	A-S Medication Solutions	50090-0488	50090-0488-1	60 TABLET in 1 BOTTLE (50090-0488-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 10, 1996	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 10, 1996	TE:	AB	RLD:	No

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