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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078638

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NDA 078638 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 eighteen suppliers. Additional details are available on the ALENDRONATE SODIUM profile page.

The generic ingredient in ALENDRONATE SODIUM is alendronate sodium. There are twenty-five drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.

Summary for 078638

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

Medical Subject Heading (MeSH) Categories for 078638

Bone Density Conservation Agents

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 70MG BASE
Approval Date:	Aug 4, 2008	TE:		RLD:	No

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