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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090617

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NDA 090617 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for 090617

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

Pharmacology for NDA: 090617

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 090617

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090617 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7823 0615-7823-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-39)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 090617 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7823 0615-7823-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7823-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Aug 1, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Aug 1, 2012TE:ABRLD:No


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