Efinaconazole

ANDA 212178, held by Zydus Lifesciences. Efinaconazole.

As of Nov 14, 2026, ANDA 212178 (Efinaconazole), held by Zydus Lifesciences, was first approved by FDA on Jul 15, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 15, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 15, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Efinaconazole10% · solution;topical	Efinaconazole	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jul 15, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212178
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters