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FDA Drug Application 019991 by NOVO NORDISK INC

Application Number	019991
Application Type	New Drug Application
Sponsor Applicant	NOVO NORDISK 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	6/25/1991	N
AP	10/7/1991	SCS
AP	3/13/1992	SCS
AP	3/26/1993	SCS
AP	3/26/1993	SLR
AP	1/7/1994	SLR
AP	4/26/1994	SCS
AP	5/23/1994	SCS
AP	5/31/1994	SCS
AP	6/16/1994	SCS
AP	6/23/1994	SCS
AP	6/23/1994	SCP
AP	1/3/1994	SLR
AP	1/4/1994	SLR
AP	5/22/1995	SCS
AP	1/28/1997	SCS
AP	6/13/1996	SCM
AP	4/10/1997	SLR
AP	1/2/1997	SCS
AP	4/16/1997	SLR	4308	021	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019991ap.pdf	4/16/1997
AP	6/20/1997	SCP
AP	8/4/1997	SCS
AP	7/24/1998	SCS
AP	5/12/1999	SCS
AP	10/18/1999	SCM
AP	3/16/2000	SCP
AP	4/10/2000	SCS
AP	6/15/2000	SLR
AP	2/21/2001	SCS
AP	12/10/2001	SLR	5339	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s31lbl.pdf	4/17/2003
AP	3/11/2002	SLR	3028	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf	3/11/2002
AP	3/11/2002	SLR	3029	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf	3/11/2002
AP	12/13/2000	SCS
AP	1/9/2001	SCS
AP	4/11/2002	SCP	3018	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf	4/11/2002
AP	4/11/2002	SCP	3019	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf	4/11/2002
AP	4/15/2002	SCP	3016	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf	4/15/2002
AP	4/15/2002	SCP	3017	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf	4/15/2002
AP	12/19/2001	SCP	5340	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19991s37lbl.pdf	4/17/2003
AP	1/10/2002	SCS
AP	6/19/2002	SCM
AP	6/15/2009	SLR	22775	067	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf	6/18/2009
AP	6/15/2009	SLR	22794	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf	6/22/2009
AP	7/17/2009	SCS	23051	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf	7/23/2009
AP	7/17/2009	SCS	23084	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf	7/24/2009
AP	6/25/2010	SCM	25845	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf	6/29/2010
AP	12/27/2010	SLR	27448	071	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf	1/4/2011
AP	6/25/2010	SLR	25846	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf	6/29/2010
AP	3/9/2013	SLR	35411	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019991Orig1s074ltr.pdf	3/12/2013
AP	3/9/2013	SLR	35434	074	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019991s074lbl.pdf	3/12/2013
AP	1/8/2016	SLR	44948	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019991Orig1s077ltr.pdf	1/11/2016
AP	1/8/2016	SLR	44963	077	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019991s077lbl.pdf	1/12/2016

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