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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Covington
Teva
Accenture
Argus Health
QuintilesIMS
Cipla
US Army

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076584

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NDA 076584 describes ALENDRONATE SODIUM, which is a drug marketed by West-ward Pharms Int, Apotex, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hangzhou Binjiang, 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 twenty-nine 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-one suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 076584
Tradename:ALENDRONATE SODIUM
Applicant:Mylan
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076584
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 076584
Suppliers and Packaging for NDA: 076584
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584 ANDA Mylan Pharmaceuticals Inc. 0378-3566 N 0378-3566-01
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584 ANDA Mylan Pharmaceuticals Inc. 0378-3567 N 0378-3567-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

Profile for product number 003

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

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Mallinckrodt
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