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Generated: December 13, 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 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 090520

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090520

Ingredient-typeDiphosphonates

Medical Subject Heading (MeSH) Categories for 090520

Suppliers and Packaging for NDA: 090520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM 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 leading biopharmaceutical companies globally:

Chubb
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