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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211618
Company: VELZEN PHARMA PVT

Products on ANDA 211618

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 211618

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/01/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211618

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	071422	PH HEALTH
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	211618	VELZEN PHARMA PVT

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