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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 091045

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NDA 091045 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, 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 forty-nine 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 091045

Tradename:	METOPROLOL TARTRATE
Applicant:	Fresenius Kabi Usa
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 091045

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 091045

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	091045	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1365	51662-1365-1	5 mL in 1 VIAL (51662-1365-1)
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	091045	ANDA	Fresenius Kabi USA, LLC	63323-660	63323-660-05	10 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Oct 25, 2010	TE:	AP	RLD:	No

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