Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211969
Company: NIVAGEN PHARMS INC

Products on ANDA 211969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/11/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211969

EFINACONAZOLE

SOLUTION;TOPICAL; 10%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	212027	ALEMBIC
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	211969	NIVAGEN PHARMS INC
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	211827	TEVA PHARMS USA
JUBLIA	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	Yes	AB	203567	BAUSCH