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Generated: June 19, 2018

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, Cipla Ltd, Dr Reddys Labs Ltd, Hangzhou Binjiang, 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 twenty-eight 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 suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 090520
Applicant:West-ward Pharms Int
Ingredient:alendronate sodium
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090520
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 N 51224-301-10

Profile 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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