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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216041
Company: AUROBINDO PHARMA LTD

Products on ANDA 216041

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 216041

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216041

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	218564	AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	216041	AUROBINDO PHARMA LTD
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 INTL
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	219058	TARO
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET;ORAL	Prescription	No	AB	202761	ZYDUS LIFESCIENCES
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	218564	AJANTA PHARMA LTD
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	216041	AUROBINDO PHARMA LTD
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 INTL
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	219058	TARO
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	No	AB	202761	ZYDUS LIFESCIENCES
SILENOR	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET;ORAL	Prescription	Yes	AB	022036	CURRAX

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