Last Updated: September 24, 2026

Details for New Drug Application (NDA): 076584

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NDA 076584 describes ALENDRONATE SODIUM, which is a drug marketed by Hikma, Novitium Pharma, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, and Watson Labs, and is included in sixteen NDAs. It is available from sixteen suppliers. Additional details are available on the ALENDRONATE SODIUM profile page.

The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

Summary for 076584

Tradename:	ALENDRONATE SODIUM
Applicant:	Rising
Ingredient:	alendronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 076584

Bone Density Conservation Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 4, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 4, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 35MG BASE
Approval Date:	Aug 4, 2008	TE:		RLD:	No

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