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Serving leading biopharmaceutical companies globally:

Healthtrust
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204205

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NDA 204205 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-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-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 204205
Tradename:METOPROLOL TARTRATE
Applicant:Gland Pharma Ltd
Ingredient:metoprolol tartrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204205
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 204205
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 204205 ANDA Alvogen Inc. 47781-587 47781-587-17 10 VIAL, SINGLE-DOSE in 1 CARTON (47781-587-17) > 5 mL in 1 VIAL, SINGLE-DOSE (47781-587-20)
METOPROLOL TARTRATE metoprolol tartrate INJECTABLE;INJECTION 204205 ANDA Gland Pharma Limited 68083-131 68083-131-01 10 VIAL, GLASS in 1 CARTON (68083-131-01) > 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Aug 27, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
US Department of Justice
Chubb
QuintilesIMS
Colorcon
McKinsey
Citi
Novartis
Argus Health

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