Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022036
Company: PERNIX THERAPS LLC
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
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.cfm 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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/17/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf

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 202337 MYLAN PHARMS INC
SILENOR DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET;ORAL Prescription Yes AB 022036 PERNIX THERAPS LLC

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 202337 MYLAN PHARMS INC
SILENOR DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET;ORAL Prescription Yes AB 022036 PERNIX THERAPS LLC

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