Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213919
Company: SUN PHARMA CANADA

Products on ANDA 213919

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213919

DOXEPIN HYDROCHLORIDE

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	No	AB	212357	AMNEAL
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	No	AB	213919	SUN PHARMA CANADA
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	No	AB	215408	TEVA PHARMS
ZONALON	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	Yes	AB	020126	MYLAN