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Serving leading biopharmaceutical companies globally:

Cipla
Cantor Fitzgerald
Federal Trade Commission
Citi
Moodys
Johnson and Johnson
Fish and Richardson
Merck
Fuji
Farmers Insurance

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090886

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NDA 090886 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 090886
Tradename:RISEDRONATE SODIUM
Applicant:Sun Pharma Global
Ingredient:risedronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090886
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 090886
Suppliers and Packaging for NDA: 090886
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886 ANDA Sun Pharma Global FZE 47335-666 47335-666-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-666-08)
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 090886 ANDA Sun Pharma Global FZE 47335-666 47335-666-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-666-18)

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:

Deloitte
Daiichi Sankyo
Accenture
Queensland Health
Harvard Business School
Cipla
US Army
Moodys
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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