Indications
Total Trials
Active Trials
Competitors
FDA Applications
NDA/BLA/ANDA regulatory filings
Timeline
Clinical
Regulatory
Jun 8, 1994
TYLENOL
NDA NDA019872
Jan 5, 1995
TYLENOL
NDA NDA019872
Jul 28, 1995
TYLENOL
NDA NDA019872
Aug 1, 1995
TYLENOL
NDA NDA019872
Jul 25, 2000
TYLENOL
NDA NDA019872
Jul 25, 2000
TYLENOL
NDA NDA019872
Dec 29, 2000
ACETAMINOPHEN
NDA ANDA075077
Jan 11, 2001
TYLENOL
NDA NDA019872
Feb 12, 2001
TYLENOL
NDA NDA019872
Jan 30, 2003
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076050
May 28, 2003
TYLENOL
NDA NDA019872
May 28, 2003
TYLENOL
NDA NDA019872
May 29, 2003
TYLENOL
NDA NDA019872
Aug 1, 2003
TYLENOL
NDA NDA019872
Mar 4, 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA075989
Mar 22, 2004
TYLENOL
NDA NDA019872
Apr 13, 2004
TYLENOL
NDA NDA019872
Jul 28, 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076050
Sep 22, 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076050
Sep 22, 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076557
Nov 3, 2004
TYLENOL
NDA NDA019872
Feb 10, 2005
ACETAMINOPHEN
NDA ANDA075077
Apr 13, 2005
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076557
Jun 21, 2005
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076050
Sep 20, 2005
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076557
Dec 4, 2007
OMEPRAZOLE
NDA NDA022032
Feb 28, 2008
TYLENOL
NDA NDA019872
Mar 27, 2009
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA075989
Apr 2, 2009
OMEPRAZOLE
NDA NDA022032
Jun 17, 2009
TYLENOL
NDA NDA019872
Sep 18, 2009
TYLENOL
NDA NDA019872
Sep 21, 2009
OMEPRAZOLE
NDA NDA022032
May 6, 2010
TYLENOL
NDA NDA019872
May 10, 2010
TYLENOL
NDA NDA019872
Jun 29, 2010
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076557
Jul 16, 2010
OMEPRAZOLE
NDA NDA022032
Oct 25, 2010
ACETAMINOPHEN
NDA ANDA075077
Jun 27, 2011
OMEPRAZOLE
NDA NDA022032
Dec 23, 2011
TYLENOL
NDA NDA019872
Apr 9, 2012
OMEPRAZOLE
NDA NDA022032
May 18, 2012
LANSOPRAZOLE
NDA ANDA202319
Sep 10, 2012
OMEPRAZOLE
NDA NDA022032
Sep 28, 2012
DEXTROMETHORPHAN POLISTIREX
NDA ANDA091135
Oct 29, 2012
OMEPRAZOLE
NDA NDA022032
Mar 26, 2013
TYLENOL
NDA NDA019872
Mar 28, 2013
TYLENOL
NDA NDA019872
Apr 5, 2013
LANSOPRAZOLE
NDA ANDA202319
Apr 5, 2013
LANSOPRAZOLE
NDA ANDA202319
Aug 16, 2013
OMEPRAZOLE
NDA NDA022032
Sep 13, 2013
OMEPRAZOLE
NDA NDA022032
Nov 30, 2013
ACETAMINOPHEN
NDA ANDA075077
Dec 20, 2013
TYLENOL
NDA NDA019872
Mar 6, 2014
TYLENOL
NDA NDA019872
Oct 21, 2014
LORATADINE AND PSEUDOEPHEDRINE SULFATE
NDA ANDA076050
Oct 27, 2014
DEXTROMETHORPHAN POLISTIREX
NDA ANDA091135
Dec 12, 2014
TYLENOL
NDA NDA019872
Dec 23, 2014
TYLENOL
NDA NDA019872
Mar 6, 2015
OMEPRAZOLE
NDA NDA022032
Mar 30, 2015
OMEPRAZOLE
NDA NDA022032
Jun 1, 2015
OMEPRAZOLE
NDA NDA022032
Jun 11, 2015
OMEPRAZOLE
NDA NDA022032
Aug 7, 2015
OMEPRAZOLE
NDA NDA022032
Sep 18, 2015
LANSOPRAZOLE
NDA ANDA202319
Jan 5, 2016
OMEPRAZOLE
NDA NDA022032
Jan 10, 2016
ACETAMINOPHEN
NDA ANDA075077
Feb 8, 2016
OMEPRAZOLE
NDA NDA022032
Feb 10, 2016
OMEPRAZOLE
NDA NDA022032
May 5, 2016
TYLENOL
NDA NDA019872
Aug 26, 2016
TYLENOL
NDA NDA019872
Dec 1, 2016
OMEPRAZOLE
NDA NDA022032
Oct 30, 2017
OMEPRAZOLE
NDA NDA022032
Nov 13, 2017
OMEPRAZOLE
NDA NDA022032
Jan 16, 2019
TYLENOL
NDA NDA019872
Apr 8, 2019
OMEPRAZOLE
NDA NDA022032
Apr 16, 2019
ACETAMINOPHEN
NDA ANDA211544
Aug 16, 2019
ACETAMINOPHEN
NDA ANDA075077
Aug 20, 2020
LANSOPRAZOLE
NDA ANDA202319
Aug 20, 2020
LANSOPRAZOLE
NDA ANDA202319
Jul 7, 2021
OMEPRAZOLE
NDA NDA022032
Aug 25, 2021
ACETAMINOPHEN
NDA ANDA215486
Oct 21, 2021
OMEPRAZOLE
NDA NDA022032
Sep 30, 2022
OMEPRAZOLE
NDA NDA022032
Jan 18, 2024
ACETAMINOPHEN
NDA ANDA211544
Sep 19, 2024
LANSOPRAZOLE
NDA ANDA202319
Sep 19, 2024
LANSOPRAZOLE
NDA ANDA202319
Sep 19, 2024
LANSOPRAZOLE
NDA ANDA202319
Nov 8, 2024
OMEPRAZOLE
NDA NDA022032
Oct 3, 2025
OMEPRAZOLE
NDA NDA022032
Sources
Details