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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077982

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NDA 077982 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 077982
Tradename:ALENDRONATE SODIUM
Applicant:Apotex
Ingredient:alendronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077982
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 077982
Suppliers and Packaging for NDA: 077982
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 077982 ANDA Preferred Pharmaceuticals, Inc. 68788-9463 68788-9463-1 10 TABLET in 1 BOTTLE (68788-9463-1)
ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 077982 ANDA Preferred Pharmaceuticals, Inc. 68788-9463 68788-9463-4 1 BLISTER PACK in 1 CARTON (68788-9463-4) > 4 TABLET in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

Profile 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:

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Cantor Fitzgerald
Fish and Richardson

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