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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207516

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NDA 207516 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 207516

Tradename:	RISEDRONATE SODIUM
Applicant:	Hangzhou Binjiang
Ingredient:	risedronate sodium
Patents:	0

Pharmacology for NDA: 207516

Medical Subject Heading (MeSH) Categories for 207516

Bone Density Conservation Agents
Calcium Channel Blockers

Suppliers and Packaging for NDA: 207516

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	207516	ANDA	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	60723-041	60723-041-04	1 BLISTER PACK in 1 CARTON (60723-041-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)
RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	207516	ANDA	Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd	60723-041	60723-041-12	3 BLISTER PACK in 1 CARTON (60723-041-12) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	35MG
Approval Date:	Feb 15, 2019	TE:		RLD:	No

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