BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Daiichi Sankyo
Fish and Richardson
Johnson and Johnson

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079215

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NDA 079215 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. Eleven suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 079215
Applicant:Teva Pharms Usa
Ingredient:risedronate sodium
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079215
Medical Subject Heading (MeSH) Categories for 079215
Suppliers and Packaging for NDA: 079215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 079215 ANDA Teva Pharmaceuticals USA, Inc. 0093-7771 N 0093-7771-79
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 079215 ANDA Teva Pharmaceuticals USA, Inc. 0093-7771 N 0093-7771-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 13, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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