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FDA Applications
NDA/BLA/ANDA regulatory filings
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Regulatory
Jan 1, 1982
DOXEPIN HYDROCHLORIDE
NDA NDA016987
Jan 1, 1982
SINEQUAN
NDA NDA016798
Jan 1, 1982
SINEQUAN
NDA NDA017516
Oct 28, 1986
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jun 22, 1989
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jul 11, 1989
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jun 30, 1993
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Nov 19, 1993
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Apr 1, 1994
ZONALON
NDA NDA020126
Nov 30, 1994
ZONALON
NDA NDA020126
Jun 29, 1995
ZONALON
NDA NDA020126
Jul 5, 1995
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Aug 1, 1996
ZONALON
NDA NDA020126
Feb 5, 1998
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Feb 25, 1998
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Dec 29, 1998
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Aug 30, 2000
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Oct 25, 2000
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Apr 30, 2002
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Dec 20, 2002
ZONALON
NDA NDA020126
Jul 8, 2005
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jul 8, 2005
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Aug 15, 2005
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Nov 14, 2005
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jun 5, 2006
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Jun 26, 2007
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Jul 11, 2007
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Apr 17, 2008
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Jul 14, 2008
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Oct 30, 2011
SILENOR
NDA NDA022036
Jul 17, 2014
DOXEPIN HYDROCHLORIDE
NDA ANDA074721
Jul 17, 2014
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Aug 8, 2014
SILENOR
NDA NDA022036
May 29, 2015
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Dec 22, 2016
SILENOR
NDA NDA022036
Jun 28, 2017
DOXEPIN HYDROCHLORIDE
NDA ANDA207482
Mar 27, 2019
DOXEPIN HYDROCHLORIDE
NDA ANDA211603
Sep 13, 2019
DOXEPIN HYDROCHLORIDE
NDA ANDA212624
Jul 24, 2020
DOXEPIN HYDROCHLORIDE
NDA ANDA202510
Jul 28, 2020
DOXEPIN HYDROCHLORIDE
NDA ANDA213474
Sep 4, 2020
DOXEPIN HYDROCHLORIDE
NDA ANDA210268
Oct 16, 2020
DOXEPIN HYDROCHLORIDE
NDA ANDA210675
Oct 29, 2020
SILENOR
NDA NDA022036
Mar 1, 2021
DOXEPIN HYDROCHLORIDE
NDA ANDA211618
Apr 1, 2021
DOXEPIN HYDROCHLORIDE
NDA ANDA214908
Apr 21, 2021
DOXEPIN HYDROCHLORIDE
NDA ANDA215076
Feb 9, 2022
DOXEPIN HYDROCHLORIDE
NDA ANDA215710
Jun 24, 2022
DOXEPIN HYDROCHLORIDE
NDA ANDA215113
Feb 17, 2023
DOXEPIN HYDROCHLORIDE
NDA ANDA215408
Apr 3, 2023
DOXEPIN HYDROCHLORIDE
NDA ANDA214823
Aug 16, 2023
DOXEPIN HYDROCHLORIDE
NDA ANDA212357
Aug 21, 2023
DOXEPIN HYDROCHLORIDE
NDA ANDA217975
Sep 22, 2023
DOXEPIN HYDROCHLORIDE
NDA ANDA202510
Jul 23, 2024
DOXEPIN HYDROCHLORIDE
NDA ANDA207482
Aug 27, 2024
DOXEPIN HYDROCHLORIDE
NDA ANDA210675
Aug 27, 2024
DOXEPIN HYDROCHLORIDE
NDA ANDA210675
Aug 6, 2025
DOXEPIN HYDROCHLORIDE
NDA ANDA219058
Jul 16, 2026
DOXEPIN HYDROCHLORIDE
NDA ANDA070791
Sep 1, 2026
DOXEPIN HYDROCHLORIDE
NDA ANDA211619
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