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Serving leading biopharmaceutical companies globally:

Cerilliant
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Fish and Richardson
US Department of Justice
Harvard Business School
Express Scripts
Medtronic
Farmers Insurance
Dow
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076768

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NDA 076768 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 076768
Tradename:ALENDRONATE SODIUM
Applicant:Cipla Ltd
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076768
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 076768
Suppliers and Packaging for NDA: 076768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076768 ANDA Actavis Pharma, Inc. 0591-3169 0591-3169-30 30 TABLET in 1 BOTTLE, PLASTIC (0591-3169-30)
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076768 ANDA Actavis Pharma, Inc. 0591-3170 0591-3170-30 30 TABLET in 1 BOTTLE, PLASTIC (0591-3170-30)

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:RXDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Boehringer Ingelheim
Covington
Cerilliant
Queensland Health
Baxter
Julphar
Argus Health

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