Last Updated: September 25, 2026

Details for New Drug Application (NDA): 212066

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NDA 212066 describes EFINACONAZOLE, which is a drug marketed by Alembic, Aurobindo Pharma Ltd, Lupin, Nivagen Pharms Inc, Padagis Us, Teva Pharms Usa, and Zydus Lifesciences, and is included in seven NDAs. Additional details are available on the EFINACONAZOLE profile page.

The generic ingredient in EFINACONAZOLE is efinaconazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.

Summary for 212066

Tradename:	EFINACONAZOLE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	efinaconazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	10%
Approval Date:	Mar 29, 2021	TE:		RLD:	No

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