Last Updated: September 24, 2026

Details for New Drug Application (NDA): 090520

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NDA 090520 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 090520

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

Pharmacology for NDA: 090520

Medical Subject Heading (MeSH) Categories for 090520

Bone Density Conservation Agents

Suppliers and Packaging for NDA: 090520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALENDRONATE SODIUM	alendronate sodium	SOLUTION;ORAL	090520	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0282	0054-0282-59	4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 70MG BASE/75ML
Approval Date:	Feb 25, 2013	TE:	AA	RLD:	No

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