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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200477


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NDA 200477 describes RISEDRONATE SODIUM, which is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orbion Pharms, and is included in fourteen NDAs. It is available from eleven suppliers. Additional details are available on the RISEDRONATE SODIUM profile page.

The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 200477
Tradename:RISEDRONATE SODIUM
Applicant:Mylan
Ingredient:risedronate sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 200477

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Nov 30, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Nov 30, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength35MG
Approval Date:Nov 30, 2015TE:RLD:No

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