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FDA Drug Application 019012 by J AND J CONSUMER INC

Application Number	019012
Application Type	New Drug Application
Sponsor Applicant	J AND J CONSUMER INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	5/18/1984	N
AP	1/23/1986	SCE
AP	12/16/1986	SCM
AP	3/31/1997	SLR
AP	7/29/1987	SCM
AP	10/2/1990	SCS
AP	7/25/1989	SCM
AP	10/2/1990	SCS
AP	12/17/1990	SCP
AP	12/17/1990	SCM
AP	3/25/1994	SCP
AP	1/10/1995	SCS
AP	11/20/1995	SCS
AP	4/10/1996	SCM
AP	2/25/2000	SE1	1237	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19012S16LTR.PDF	2/25/2000
AP	2/25/2000	SE1	3642	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf	2/25/2000
AP	2/25/2000	SE1	3643	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016.cfm	5/14/2002
AP	8/25/2000	SLR
AP	12/6/1999	SCP
AP	2/7/2000	SCM
AP	11/21/1999	SCM
AP	11/21/1999	SCM
AP	3/22/2000	SCP
AP	3/22/2000	SCM
AP	10/2/2000	SLR
AP	1/3/2001	SCS
AP	3/5/2001	SCM
AP	5/2/2001	SCS
AP	9/7/2001	SLR	5317	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf	4/16/2003
AP	3/27/2002	SCM
AP	10/28/2003	SLR	6851	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf	10/31/2003
AP	2/8/2006	SLR	13658	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s037ltr.pdf	2/22/2006
AP	12/8/2006	SCP	15565	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s038ltr.pdf	12/28/2006
AP	11/20/2007	SLR	18574	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019012s040_CKD.pdf	11/26/2007
AP	4/24/2009	SLR	22382	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019012s043ltr.pdf	5/1/2009
AP	10/21/2010	SLR	26775	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019012s046ltr.pdf	10/26/2010
AP	10/21/2010	SLR	32238	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf	3/27/2012
AP	12/4/2012	SCM
AP	3/28/2013	SCM
AP	3/11/2014	SCM	44389	052	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/019012Orig1s052.pdf	11/5/2015
AP	7/31/2015	SCM	44390	053	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/019012Orig1s053.pdf	11/5/2015
AP	5/6/2016	SCM
AP	8/18/2016	SLR	46817	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019012Orig1s055ltr.pdf	8/19/2016
AP	8/18/2016	SLR	46841	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf	8/22/2016

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