Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210038
Company: XIROMED

Products on ANDA 210038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2020	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
10/06/2022	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210038

NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	No	AB	206901	SUN PHARMA CANADA
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	No	AB	210038	XIROMED
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	Yes	AB	019599	LEGACY PHARMA