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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Cantor Fitzgerald
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Federal Trade Commission
Cerilliant
Baxter
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Covington

Generated: December 14, 2017

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, 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 076584

Tradename:1
Applicant:1
Ingredient:1
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 0378-3566-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-3566-01)
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076584 ANDA Mylan Pharmaceuticals Inc. 0378-3567 0378-3567-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-3567-01)

Summary for product number 001

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

Summary for product number 002

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

Summary 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:

Boehringer Ingelheim
Medtronic
Harvard Business School
Fuji
Novartis
Dow
Moodys
Colorcon
AstraZeneca
Baxter

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