An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202337
Company: RK PHARMA

Products on ANDA 202337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202337

DOXEPIN HYDROCHLORIDE

TABLET;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	201951	ACTAVIS ELIZABETH
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	214823	MSN
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	202337	RK PHARMA
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	202510	STRIDES PHARMA
SILENOR	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	Yes	AB	022036	CURRAX

TABLET;ORAL; EQ 6MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	201951	ACTAVIS ELIZABETH
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	214823	MSN
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	202337	RK PHARMA
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	202510	STRIDES PHARMA
SILENOR	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	Yes	AB	022036	CURRAX

Top