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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 200477

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NDA 200477 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 Ltd, 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 are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

Summary for 200477

Tradename:	RISEDRONATE SODIUM
Applicant:	Pharmobedient
Ingredient:	risedronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 200477

Bone Density Conservation Agents
Calcium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 30, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Nov 30, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	Nov 30, 2015	TE:		RLD:	No

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