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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078889

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NDA 078889 describes METOPROLOL SUCCINATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Cipla, Dr Reddys Labs Ltd, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Reddys, Sandoz, Twi Pharms, Wockhardt, and Zydus Pharms, and is included in fifteen NDAs. It is available from thirty-four 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 suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 078889
Tradename:METOPROLOL SUCCINATE
Applicant:Reddys
Ingredient:metoprolol succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078889
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 078889
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 078889 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7825 0615-7825-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7825-39)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 078889 ANDA Major Pharmaceuticals 0904-6324 0904-6324-61 100 BLISTER PACK in 1 CARTON (0904-6324-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Aug 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:Aug 15, 2012TE:ABRLD:No

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