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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077739

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NDA 077739 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 077739

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

Pharmacology for NDA: 077739

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 077739

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 077739 ANDA Blenheim Pharmacal, Inc. 10544-298 10544-298-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-298-90)
METOPROLOL TARTRATE metoprolol tartrate TABLET;ORAL 077739 ANDA Apotheca Inc. 12634-771 12634-771-92 2 TABLET, FILM COATED in 1 BOTTLE (12634-771-92)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 11, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 11, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 11, 2007TE:ABRLD:No


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