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Details for New Drug Application (NDA): 090877

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NDA 090877 describes RISEDRONATE SODIUM, which is a drug marketed by Teva Pharms Usa, Macleods Pharms Ltd, Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Aurobindo Pharma Ltd, and is included in eight NDAs. It is available from seven 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. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.

Summary for NDA: 090877

Apotex Inc
risedronate sodium
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090877


Suppliers and Packaging for NDA: 090877

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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