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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 090877


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NDA 090877 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 090877
Tradename:RISEDRONATE SODIUM
Applicant:Apotex
Ingredient:risedronate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090877
Medical Subject Heading (MeSH) Categories for 090877
Suppliers and Packaging for NDA: 090877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090877 ANDA Apotex Corp. 60505-3096 60505-3096-2 1 BLISTER PACK in 1 CARTON (60505-3096-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090877 ANDA Apotex Corp. 60505-3097 60505-3097-2 1 BLISTER PACK in 1 CARTON (60505-3097-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Jun 10, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 10, 2014TE:ABRLD:No

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