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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 020706

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NDA 020706 describes EMADINE, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the EMADINE profile page.

The generic ingredient in EMADINE is emedastine difumarate. There is one drug master file entry for this compound. Additional details are available on the emedastine difumarate profile page.

Summary for 020706

Tradename:	EMADINE
Applicant:	Novartis
Ingredient:	emedastine difumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Dec 29, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020706

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EMADINE	emedastine difumarate	SOLUTION/DROPS;OPHTHALMIC	020706-001	Dec 29, 1997	4,430,343	⤷ Get Started Free
Novartis	EMADINE	emedastine difumarate	SOLUTION/DROPS;OPHTHALMIC	020706-001	Dec 29, 1997	5,441,958	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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