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Last Updated: November 30, 2021

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, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Reddys, Sandoz, Twi Pharms, Wockhardt, Yichang Humanwell, and Zydus Pharms, and is included in twenty NDAs. It is available from forty suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 090617
Tradename:METOPROLOL SUCCINATE
Applicant:Dr Reddys Labs Ltd
Ingredient:metoprolol succinate
Patents:0
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 0615-7823-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-05)
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

Profile for product number 001

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

Profile 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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