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FDA Drug Application 050405 by PRAGMA PHARMS LLC

Application Number	050405
Application Type	New Drug Application
Sponsor Applicant	PRAGMA PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type
Therapeutic Potential
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/4/1971	N
AP	9/5/1984	SCS
AP	2/8/1971	SCS
AP	11/4/1985	SCS
AP	11/22/1985	SLR
AP	8/21/1986	SE1
AP	7/7/1971	SLR
AP	8/6/1971	SLR
AP	8/29/1986	SLR
AP	3/4/1987	SCM
AP	3/4/1987	SLR
AP	2/17/1987	SE1
AP	9/21/1988	SLR
AP	4/10/1990	SLR
AP	8/27/1992	SLR
AP	10/9/1991	SCS
AP	1/7/1971	SCM
AP	4/14/1971	SLR
AP	5/13/1971	SLR
AP	5/19/1971	SLR
AP	7/1/1971	SLR
AP	10/19/1971	SCE
AP	10/6/1971	SLR
AP	11/30/1971	SCS
AP	12/13/1971	SCS
AP	1/12/1972	SCS
AP	2/24/1972	SLR
AP	12/13/1972	SLR
AP	7/19/1972	SCS
AP	12/13/1972	SLR
AP	1/18/1973	SCS
AP	2/15/1973	SCS
AP	4/27/1973	SLR
AP	6/4/1973	SLR
AP	6/19/1973	SLR
AP	6/25/1973	SLR
AP	7/25/1973	SCS
AP	7/31/1973	SLR
AP	10/2/1973	SLR
AP	11/8/1973	SCE
AP	1/15/1974	SCS
AP	1/24/1974	SCS
AP	2/20/1974	SCE
AP	3/6/1974	SLR
AP	6/28/1974	SLR
AP	5/24/1974	SLR
AP	7/10/1974	SCF
AP	8/16/1974	SLR
AP	8/22/1974	SLR
AP	8/28/1974	SLR
AP	10/4/1974	SE1
AP	9/3/1974	SLR
AP	10/2/1974	SLR
AP	12/13/1974	SLR
AP	4/7/1975	SCE
AP	7/8/1975	SLR
AP	7/31/1975	SCS
AP	8/4/1975	SLR
AP	8/12/1975	SLR
AP	9/4/1975	SLR
AP	9/8/1975	SLR
AP	9/16/1975	SLR
AP	10/24/1975	SLR
AP	11/17/1975	SLR
AP	3/10/1976	SCS
AP	3/10/1976	SCS
AP	4/9/1976	SLR
AP	4/22/1976	SLR
AP	6/8/1976	SLR
AP	8/10/1976	SCS
AP	9/2/1976	SLR
AP	9/8/1976	SLR
AP	9/8/1976	SLR
AP	12/10/1976	SCS
AP	12/10/1976	SCS
AP	12/17/1976	SLR
AP	2/28/1977	SLR
AP	3/9/1977	SCS
AP	3/15/1977	SCS
AP	4/22/1977	SLR
AP	4/28/1977	SCE
AP	5/25/1977	SCM
AP	11/4/1988	SCM
AP	2/13/1995	SLR
AP	5/15/1996	SLR
AP	7/27/2001	SCM
AP	11/19/2004	SLR	10665	092	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405s092ltr.pdf	12/2/2004
AP	10/23/2002	SCS
AP	1/15/2004	SLR	7594	094	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr094ltr.pdf	1/22/2004
AP	1/15/2004	SLR	7616	094	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf	1/22/2004
AP	6/25/2004	SLR	9689	095	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr095ltr.pdf	7/1/2004
AP	5/12/2006	SE8	14102	097	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf	5/16/2006
AP	5/12/2006	SE8	14104	097	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050405s097ltr.pdf	5/16/2006
AP	5/21/2008	SLR	19869	099	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s099ltr.pdf	5/21/2008
AP	9/16/2008	SLR	20789	101	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s101ltr.pdf	9/17/2008
AP	12/30/2013	SCM
AP	10/30/2015	SLR	44361	106	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf	11/4/2015
AP	10/30/2015	SLR	44363	106	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050405s106lbl.pdf	11/4/2015

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