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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 090022


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NDA 090022 describes ALENDRONATE SODIUM, which is a drug marketed by Hikma, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Picket Pharms, Rising, Sun Pharm, Teva Pharms, and Watson Labs, and is included in fourteen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 090022
Tradename:ALENDRONATE SODIUM
Applicant:Sun Pharm
Ingredient:alendronate sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090022

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 10, 2008TE:ABRLD:No

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 35MG BASE
Approval Date:Sep 10, 2008TE:ABRLD:No

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