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Serving leading biopharmaceutical companies globally:

Queensland Health
Citi
QuintilesIMS
Baxter
US Department of Justice
Daiichi Sankyo
AstraZeneca
US Army
McKesson
Dow

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078085

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NDA 078085 describes METOPROLOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Luitpold, Sagent Strides, Sandoz Inc, Watson Labs, West-ward Pharms Int, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Ipca Labs Ltd, Mylan, Prinston Inc, Purepac Pharm, Rubicon Res Pvt Ltd, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, and Sun Pharm Inds, and is included in thirty-four NDAs. It is available from sixty-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-one 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 078085

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078085

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 078085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 078085 ANDA Hospira, Inc. 0409-1778 0409-1778-05 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1778-05) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-1778-15)
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 078085 ANDA Hospira, Inc. 0409-1778 0409-1778-35 3 CARTRIDGE in 1 CARTON (0409-1778-35) > 5 mL in 1 CARTRIDGE (0409-1778-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Apr 29, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
US Army
Novartis
Fish and Richardson
Argus Health
Chubb
Dow
Harvard Business School
Mallinckrodt

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