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Serving leading biopharmaceutical companies globally:

Express Scripts
QuintilesIMS
UBS
Moodys
Colorcon
Daiichi Sankyo
Novartis
Harvard Business School
Covington
US Army

Generated: February 25, 2018

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, Mylan Asi, Sandoz Inc, Watson Labs, West-ward Pharms Int, Alembic Pharms Ltd, Apothecon, Aurobindo Pharma, Ipca Labs Ltd, Mylan, Purepac Pharm, Renata, Rubicon Res Pvt Ltd, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms, Yaopharma Co Ltd, and Sun Pharm Inds, and is included in thirty-four NDAs. It is available from sixty-three 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. Eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.
Summary for 078085
Tradename:METOPROLOL TARTRATE
Applicant:Hospira
Ingredient:metoprolol tartrate
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 N 0409-1778-05
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 078085 ANDA Hospira, Inc. 0409-1778 N 0409-1778-35

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Fish and Richardson
Cipla
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Boehringer Ingelheim
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Julphar
Baxter

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