Last Updated: May 3, 2026

Details for New Drug Application (NDA): 212027

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NDA 212027 describes EFINACONAZOLE, which is a drug marketed by Alembic, Aurobindo Pharma Ltd, Lupin Ltd, 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 are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.

Summary for 212027

Tradename:	EFINACONAZOLE
Applicant:	Alembic
Ingredient:	efinaconazole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	10%
Approval Date:	Feb 23, 2026	TE:	AB	RLD:	No

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