Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214512

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NDA 214512 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 214512

Tradename:	ALENDRONATE SODIUM
Applicant:	Novitium Pharma
Ingredient:	alendronate sodium
Patents:	0

Pharmacology for NDA: 214512

Medical Subject Heading (MeSH) Categories for 214512

Bone Density Conservation Agents

Suppliers and Packaging for NDA: 214512

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALENDRONATE SODIUM	alendronate sodium	SOLUTION;ORAL	214512	ANDA	ANI Pharmaceuticals, Inc.	70954-264	70954-264-10	4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 70MG BASE/75ML
Approval Date:	May 11, 2023	TE:	AA	RLD:	No

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