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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076704

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NDA 076704 describes METOPROLOL TARTRATE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Luitpold, Sandoz, Steriscience Speclts, Watson Labs, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Chartwell Rx, Heritage Pharma, Ipca Labs Ltd, Mylan, Norvium Bioscience, Purepac Pharm, Renata, Rubicon, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Youngtech Pharms Inc, Zydus Pharms, Alembic, and Sun Pharm Inds, and is included in thirty-six NDAs. It is available from fifty-five 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 076704

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

Pharmacology for NDA: 076704

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 076704

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	076704	ANDA	Mylan Pharmaceuticals Inc.	0378-0018	0378-0018-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-01)
METOPROLOL TARTRATE	metoprolol tartrate	TABLET;ORAL	076704	ANDA	Mylan Pharmaceuticals Inc.	0378-0018	0378-0018-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0018-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jan 16, 2004	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jan 16, 2004	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 16, 2004	TE:	AB	RLD:	No

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