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Last Updated: December 13, 2024

Details for New Drug Application (NDA): 076969


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NDA 076969 describes METOPROLOL SUCCINATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in twenty-seven NDAs. It is available from forty-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-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 076969
Tradename:METOPROLOL SUCCINATE
Applicant:Sandoz
Ingredient:metoprolol succinate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Jul 31, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:May 18, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Mar 20, 2008TE:RLD:No

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