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Generated: July 23, 2017

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 Wockhardt, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Mylan Pharms Inc, Nesher Pharms, Actavis Elizabeth, Sandoz, and Reddys, and is included in twelve NDAs. It is available from thirty-six 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for NDA: 090615

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Cipla
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Mallinckrodt

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