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Serving leading biopharmaceutical companies globally:

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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090615

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NDA 090615 describes METOPROLOL SUCCINATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Mylan Pharms Inc, Nesher Pharms, Reddys, Sandoz, and Wockhardt, and is included in twelve NDAs. It is available from thirty-seven suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are fifty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 090615
Tradename:METOPROLOL SUCCINATE
Applicant:Wockhardt
Ingredient:metoprolol succinate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090615
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 090615
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090615 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6589 0615-6589-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-6589-39)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090615 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6597 0615-6597-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-6597-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Jul 22, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Jul 22, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Jul 22, 2010TE:ABRLD:No

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