Last Updated: November 13, 2026

Details for New Drug Application (NDA): 204205

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NDA 204205 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, Adaptis, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Pharmobedient, Purepac Pharm, Rubicon Research, Sciegen Pharms, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Zydus Pharms, Alembic, Pharmazone, and Sun Pharm Inds, and is included in thirty-seven NDAs. It is available from forty-eight suppliers. Additional details are available on the METOPROLOL TARTRATE profile page.

The generic ingredient in METOPROLOL TARTRATE is hydrochlorothiazide; metoprolol tartrate. There are 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 204205

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

Pharmacology for NDA: 204205

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 204205

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	204205	ANDA	Sagent Pharmaceuticals	25021-303	25021-303-05	10 VIAL in 1 CARTON (25021-303-05) / 5 mL in 1 VIAL
METOPROLOL TARTRATE	metoprolol tartrate	INJECTABLE;INJECTION	204205	ANDA	Gland Pharma Limited	68083-131	68083-131-01	10 VIAL, GLASS in 1 CARTON (68083-131-01) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Aug 27, 2014	TE:	AP	RLD:	No

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