Last Updated: September 28, 2026

Details for New Drug Application (NDA): 203217

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NDA 203217 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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

Summary for 203217

Tradename:	RISEDRONATE SODIUM
Applicant:	Teva Pharms Usa
Ingredient:	risedronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 203217

Bone Density Conservation Agents
Calcium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	35MG
Approval Date:	May 18, 2015	TE:	AB	RLD:	No

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