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Last Updated: December 12, 2025

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 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 203925

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

Pharmacology for NDA: 203925

Medical Subject Heading (MeSH) Categories for 203925

Bone Density Conservation Agents
Calcium Channel Blockers

Suppliers and Packaging for NDA: 203925

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISEDRONATE SODIUM	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	203925	ANDA	Sun Pharmaceutical Industires Inc.	63304-440	63304-440-09	1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)

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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