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Generated: June 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090520

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NDA 090520 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: 090520

Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090520


Suppliers and Packaging for NDA: 090520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
alendronate sodium
SOLUTION;ORAL 090520 ANDA TAGI Pharma, Inc. 51224-301 51224-301-10 4 BOTTLE, UNIT-DOSE in 1 CARTON (51224-301-10) > 75 mL in 1 BOTTLE, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 70MG BASE/75ML
Approval Date:Feb 25, 2013TE:RLD:No

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
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