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US Department of Justice
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Harvard Business School

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200477

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NDA 200477 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 200477
Tradename:RISEDRONATE SODIUM
Applicant:Mylan Pharms Inc
Ingredient:risedronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200477
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 200477
Suppliers and Packaging for NDA: 200477
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477 ANDA Mylan Pharmaceuticals Inc. 0378-4044 N 0378-4044-93
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200477 ANDA Mylan Pharmaceuticals Inc. 0378-4114 N 0378-4114-93

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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