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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 205066

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NDA 205066 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, Norvium Bioscience, and Orbion Pharms, and is included in fourteen NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

Summary for 205066

Tradename:	RISEDRONATE SODIUM
Applicant:	Impax Labs Inc
Ingredient:	risedronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 205066

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:	Jun 29, 2018	TE:		RLD:	No

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