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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Merck
UBS
Dow
Cantor Fitzgerald
US Army
Cipla
Queensland Health
Citi

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090258

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NDA 090258 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-eight 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 suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 090258
Tradename:ALENDRONATE SODIUM
Applicant:Hangzhou Binjiang
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090258
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 090258
Suppliers and Packaging for NDA: 090258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090258 ANDA Golden State Medical Supply, Inc. 60429-055 N 60429-055-72
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090258 ANDA Golden State Medical Supply, Inc. 60429-056 N 60429-056-72

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 24, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 24, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Sep 24, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Healthtrust
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Federal Trade Commission
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