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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Department of Justice
QuintilesIMS
Mallinckrodt
McKesson
Baxter
AstraZeneca
Queensland Health
Covington

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076704

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NDA 076704 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-four 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. Eight 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
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076704
Mechanism of ActionAdrenergic 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 N 0378-0018-01
METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 076704 ANDA Mylan Pharmaceuticals Inc. 0378-0018 N 0378-0018-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 16, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 16, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 16, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Army
Argus Health
Dow
Farmers Insurance
McKinsey
Johnson and Johnson
Fuji
Citi

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