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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Colorcon
Covington
Teva
Baxter
UBS
Dow
Cipla
Chinese Patent Office
Merck

Generated: June 27, 2017

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Details for New Drug Application (NDA): 076768

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NDA 076768 describes ALENDRONATE SODIUM, which is a drug marketed by Impax Labs Inc, West-ward Pharms Int, Sun Pharma Global, Aurobindo Pharma, Mylan, Dr Reddys Labs Ltd, Jubilant Cadista, Austarpharma Llc, Cipla Ltd, Upsher-smith Labs, Apotex, Teva Pharms, and Watson Labs, and is included in fourteen NDAs. It is available from twenty-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

Summary for NDA: 076768

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076768

Ingredient-typeDiphosphonates

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 Watson Laboratories, Inc. 0591-3169 0591-3169-30 30 TABLET in 1 BOTTLE, PLASTIC (0591-3169-30)
ALENDRONATE SODIUM
alendronate sodium
TABLET;ORAL 076768 ANDA Watson Laboratories, Inc. 0591-3170 0591-3170-30 30 TABLET in 1 BOTTLE, PLASTIC (0591-3170-30)

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 500+ biopharmaceutical companies globally:

Colorcon
Chinese Patent Office
Moodys
Queensland Health
McKesson
QuintilesIMS
Citi
McKinsey
Cantor Fitzgerald
Healthtrust

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