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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022036
Company: CURRAX

Summary Review

Products on NDA 022036

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022036

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022036s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036s000_silenor_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022036Orig1s006ltr.pdf
12/22/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/08/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/30/2011	SUPPL-1	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022036s001ltr.pdf

Labels for NDA 022036

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf
03/17/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf

Therapeutic Equivalents for NDA 022036

SILENOR

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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