Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208201
Company: SUN PHARMA CANADA

Products on ANDA 208201

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208201

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208201Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/28/2019	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208201

NAFTIFINE HYDROCHLORIDE

GEL;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%	GEL;TOPICAL	Prescription	No	AB	208201	SUN PHARMA CANADA
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	GEL;TOPICAL	Prescription	Yes	AB	204286	LEGACY PHARMA