Application 212027

Type: ANDA
Sponsor: ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFINACONAZOLE	EFINACONAZOLE	UNKNOWN	UNKNOWN	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212027-001	EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION / TOPICAL			2026-02-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A212027-001	EFINACONAZOLE	10%	SOLUTION / TOPICAL		2026-02-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212027-001	EFINACONAZOLE	10%	SOLUTION / TOPICAL		2026-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212027-001	EFINACONAZOLE	10%	SOLUTION / TOPICAL	AB	2026-02-23	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212027-001	EFINACONAZOLE	10%	SOLUTION / TOPICAL	AB	2026-02-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212027-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212027-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JUBLIA	EFINACONAZOLE	Bausch Health US LLC	922d4d25-c530-11e1-9b21-0800200c9a66	2025-07-01	Adverse reactions	Name fallback generic name: EFINACONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67420	ORIG	2021-05-06