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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202871

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NDA 202871 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 202871

Tradename:	METOPROLOL TARTRATE
Applicant:	Alembic Pharms Ltd
Ingredient:	metoprolol tartrate
Patents:	0

Pharmacology for NDA: 202871

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 202871

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	202871	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8421	0615-8421-05	15 TABLET in 1 BLISTER PACK (0615-8421-05)
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	202871	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8421	0615-8421-30	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8421-30) / 5 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 28, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 28, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 28, 2013	TE:	AB	RLD:	No

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