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Serving leading biopharmaceutical companies globally:

McKesson
Novartis
US Army
Fish and Richardson
Moodys
Dow
Farmers Insurance
AstraZeneca
Citi
Cantor Fitzgerald

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076984

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NDA 076984 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 076984
Tradename:ALENDRONATE SODIUM
Applicant:Watson Labs
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076984
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 076984
Suppliers and Packaging for NDA: 076984
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076984 ANDA Actavis Pharma, Inc. 16252-599 16252-599-02 3 BLISTER PACK in 1 BOX, UNIT-DOSE (16252-599-02) > 4 TABLET in 1 BLISTER PACK
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076984 ANDA Actavis Pharma, Inc. 16252-599 16252-599-44 1 BLISTER PACK in 1 BOX, UNIT-DOSE (16252-599-44) > 4 TABLET in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Aug 4, 2008TE:ABRLD:No

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

Teva
Medtronic
Fuji
UBS
Julphar
Express Scripts
Johnson and Johnson
Merck
Covington

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