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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078950

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NDA 078950 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 078950

Tradename:	METOPROLOL TARTRATE
Applicant:	Baxter Hlthcare Corp
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 078950

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 078950

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	078950	ANDA	Baxter Healthcare Corporation	36000-033	36000-033-10	10 VIAL in 1 CARTON (36000-033-10) / 5 mL in 1 VIAL
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	078950	ANDA	Cardinal Health 107, LLC	55154-4451	55154-4451-5	5 VIAL in 1 BAG (55154-4451-5) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Apr 29, 2013	TE:	AP	RLD:	No

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