Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201951
Company: ACTAVIS ELIZABETH
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/26/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/03/2020 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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
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
SILENOR DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET;ORAL Prescription Yes AB 022036 CURRAX

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