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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 019545

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NDA 019545 describes DIDRONEL, which is a drug marketed by Mgi Pharma Inc and Apil and is included in two NDAs. Additional details are available on the DIDRONEL profile page.

The generic ingredient in DIDRONEL 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 019545

Tradename:	DIDRONEL
Applicant:	Mgi Pharma Inc
Ingredient:	etidronate disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Apr 20, 1987	TE:		RLD:	No

Expired US Patents for NDA 019545

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987	⤷ Get Started Free	⤷ Get Started Free
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987	⤷ Get Started Free	⤷ Get Started Free
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987	⤷ Get Started Free	⤷ Get Started Free
Mgi Pharma Inc	DIDRONEL	etidronate disodium	INJECTABLE;INJECTION	019545-001	Apr 20, 1987	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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