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Harvard Business School
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Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078638

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NDA 078638 describes ALENDRONATE SODIUM, which is a drug marketed by West-ward Pharms Int, Apotex, Aurobindo Pharma, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Impax Labs Inc, Jubilant Cadista, Mylan, Sun Pharma Global, Teva Pharms, Upsher-smith Labs, and Watson Labs, and is included in fourteen NDAs. It is available from thirty suppliers. Additional details are available on the ALENDRONATE SODIUM profile page.

The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 078638
Tradename:ALENDRONATE SODIUM
Applicant:Mylan
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078638

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Aug 4, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 70MG BASE
Approval Date:Aug 4, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Cerilliant
Deloitte
Julphar
Daiichi Sankyo
US Army
Federal Trade Commission
Colorcon
Citi
AstraZeneca

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