Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203533

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NDA 203533 describes RISEDRONATE SODIUM, which is a drug marketed by Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms, Orbion Pharms, and Pharmobedient, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the RISEDRONATE SODIUM profile page.

The generic ingredient in RISEDRONATE SODIUM is risedronate sodium. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 203533
Tradename:RISEDRONATE SODIUM
Applicant:Macleods Pharms
Ingredient:risedronate sodium
Patents:0
Pharmacology for NDA: 203533
Medical Subject Heading (MeSH) Categories for 203533
Bone Density Conservation Agents
Calcium Channel Blockers
Suppliers and Packaging for NDA: 203533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 33342-107-06 3 BLISTER PACK in 1 CARTON (33342-107-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533 ANDA Macleods Pharmaceuticals Limited 33342-107 33342-107-07 30 TABLET, FILM COATED in 1 CONTAINER (33342-107-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 9, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Dec 9, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Nov 29, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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