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Generated: October 20, 2018

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Details for New Drug Application (NDA): 076969

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NDA 076969 describes METOPROLOL SUCCINATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Reddys, Sandoz, Wockhardt, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from forty-two suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are fifty-nine drug master file entries for this compound. Forty-eight 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
Formulation / Manufacturing:see details

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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