Last Updated: September 24, 2026

Details for New Drug Application (NDA): 206387

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NDA 206387 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 206387

Tradename:	ALENDRONATE SODIUM
Applicant:	Ipca Labs Ltd
Ingredient:	alendronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 206387

Bone Density Conservation Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 4, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 35MG BASE
Approval Date:	Jun 4, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE
Approval Date:	Jun 4, 2024	TE:	AB	RLD:	No

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