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): 213796
Company: EDENBRIDGE PHARMS

Products on ANDA 213796

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213796

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213796Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213796

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG 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 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	213796	EDENBRIDGE PHARMS
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	211618	LEADING
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	071422	PAR PHARM
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	210140	ZYDUS LIFESCIENCES

Top