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FDA Drug Application 016620 by ALVOGEN MALTA

Application Number	016620
Application Type	New Drug Application
Sponsor Applicant	ALVOGEN MALTA
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/5/1970	N
AP	7/15/1976	SCP	17223	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S016_Macrodantin Capsules.pdf	7/9/2007
AP	7/21/1976	SCM	17224	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S017_Macrodantin Capsules.pdf	7/9/2007
AP	7/21/1976	SCP	17217	018	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S018_Macodantin.pdf	7/9/2007
AP	11/22/1976	SCP	17215	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S019_Macrodantin Capsules.pdf	7/9/2007
AP	3/21/1977	SCS	17216	020	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S020_Macrodantin Capsules.pdf	7/9/2007
AP	5/13/1977	SCS
AP	7/28/1978	SLR
AP	7/26/1979	SCP
AP	12/18/1979	SLR
AP	7/16/1979	SCM
AP	5/20/1980	SCP
AP	8/14/1980	SCF
AP	10/15/1982	SLR
AP	12/12/1980	SLR
AP	5/13/1982	SCP
AP	5/18/1993	SLR
AP	6/2/1983	SCM
AP	7/9/1984	SCM
AP	5/19/1993	SLR
AP	5/13/1988	SLR	14082	045	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm	5/10/2006
AP	1/3/1989	SCM	15843	047	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16620_S047_MacrodantinTOC.cfm	2/20/2007
AP	9/11/1990	SCM
AP	7/9/1990	SCP
AP	4/10/1991	SCS
AP	12/8/1992	SCM
AP	12/8/1992	SCP	19149	053	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S053_MACRODANTIN.pdf	2/19/2008
AP	12/8/1992	SCF	19150	054	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S054_MACRODANTIN.pdf	2/19/2008
AP	12/8/1992	SCS	19152	055	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S055_MACRODANTIN.pdf	2/19/2008
AP	2/17/1998	SLR
AP	8/9/1993	SCS	19151	057	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S057_MACRODANTIN.pdf	2/19/2008
AP	2/17/1998	SLR
AP	3/7/1996	SCS	19153	059	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S059_MACRODANTIN.pdf	2/19/2008
AP	7/30/1996	SCM
AP	3/27/1997	SLR
AP	7/16/1997	SLR	20566	062	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016620_S062_MACRODANTIN.pdf	8/11/2008
AP	10/21/1998	SCS	20554	063	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016620_S063_MACRODANTIN.pdf	8/11/2008
AP	2/4/2003	SLR	4769	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16620slr064ltr.pdf	2/4/2003
AP	2/4/2003	SLR	20396	064	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016620_S064_MACRODANTIN.pdf	8/1/2008
AP	3/29/2004	SLR	8288	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf	4/5/2004
AP	3/29/2004	SLR	8316	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16620slr065ltr.pdf	4/7/2004
AP	3/29/2004	SLR	20390	065	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016620_S065_MACRODANTIN.pdf	7/31/2008
AP	9/14/2007	SLR	17904	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf	9/19/2007
AP	9/14/2007	SLR	17944	067	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016620s067ltr.pdf	9/25/2007
AP	3/5/2009	SLR	21964	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016620s068ltr.pdf	3/6/2009
AP	3/5/2009	SLR	22013	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf	3/17/2009
AP	6/6/2011	SLR	29071	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf	6/9/2011
AP	9/6/2013	SLR	37006	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf	9/9/2013
AP	9/6/2013	SLR	37039	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016620Orig1s072ltr.pdf	9/10/2013
AP	10/2/2015	SCM
AP	10/15/2015	SCM

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