Last Updated: November 8, 2026

Details for New Drug Application (NDA): 214523

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NDA 214523 describes ALENDRONATE SODIUM, which is a drug marketed by Hikma, Novitium Pharma, Precision Dose Inc, 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 seventeen 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 214523

Tradename:	ALENDRONATE SODIUM
Applicant:	Precision Dose Inc
Ingredient:	alendronate sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 214523

Bone Density Conservation Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 70MG BASE/75ML
Approval Date:	Sep 2, 2026	TE:	AA	RLD:	No

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