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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075800

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NDA 075800 describes ETIDRONATE DISODIUM, which is a drug marketed by Pharmobedient and is included in one NDA. Additional details are available on the ETIDRONATE DISODIUM profile page.

The generic ingredient in ETIDRONATE DISODIUM is etidronate disodium. There are four drug master file entries for this compound. Additional details are available on the etidronate disodium profile page.

Summary for 075800

Tradename:	ETIDRONATE DISODIUM
Applicant:	Pharmobedient
Ingredient:	etidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 24, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jan 24, 2003	TE:		RLD:	No

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