Last Updated: November 13, 2026

Details for New Drug Application (NDA): 203925

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NDA 203925 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 203925

Tradename:	RISEDRONATE SODIUM
Applicant:	Sun Pharm
Ingredient:	risedronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 203925

Bone Density Conservation Agents
Calcium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	35MG
Approval Date:	Jul 9, 2019	TE:		RLD:	No

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