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Serving leading biopharmaceutical companies globally:

Argus Health
Mallinckrodt
AstraZeneca
US Department of Justice
Baxter
Queensland Health
Accenture
Medtronic
Daiichi Sankyo
Moodys

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200296

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NDA 200296 describes RISEDRONATE SODIUM, which is a drug marketed by Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Sun Pharma Global, and is included in nine 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. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 200296
Tradename:RISEDRONATE SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:risedronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200296
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 200296
Suppliers and Packaging for NDA: 200296
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296 ANDA Aurobindo Pharma Limited 65862-517 65862-517-78 10 BLISTER PACK in 1 CARTON (65862-517-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-517-10)
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296 ANDA Aurobindo Pharma Limited 65862-517 65862-517-22 2000 TABLET, FILM COATED in 1 BOTTLE (65862-517-22)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Johnson and Johnson
Baxter
Fish and Richardson
Fuji
Chinese Patent Office
Harvard Business School
Chubb

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