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FDA Drug Application 021135 by LUITPOLD

Application Number	021135
Application Type	New Drug Application
Sponsor Applicant	LUITPOLD
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	11/6/2000	N	2262	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21135ltr.pdf	11/13/2000
AP	0	11/6/2000	N	9613	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf	6/29/2004
AP	0	11/6/2000	N	9614	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.cfm	6/29/2004
AP	0	2/13/2001	SLR
AP	0	1/22/2002	SCS
AP	0	12/5/2002	SCS
AP	0	7/26/2002	SCS	5838	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-005ltr.pdf	6/8/2003
AP	0	7/26/2002	SCS	5890	005	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf	6/8/2003
AP	0	6/2/2003	SE2	6136	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-006ltr.pdf	7/24/2003
AP	0	6/17/2005	SE1	11845	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf	6/21/2005
AP	0	6/17/2005	SE1	11850	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf	6/21/2005
AP	0	6/17/2005	SE1	20332	008	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf	7/30/2008
AP	1	6/17/2005	S	11845	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf	6/21/2005
AP	1	6/17/2005	S	11850	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf	6/21/2005
AP	1	6/17/2005	S	20332	008	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf	7/30/2008
AP	0	3/29/2005	SCP	11341	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s010ltr.pdf	3/31/2005
AP	0	10/17/2005	SE1	12888	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s013ltr.pdf	10/19/2005
AP	0	10/17/2005	SE1	12900	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf	10/19/2005
AP	1	2/9/2007	SCP	15864	015	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf	2/21/2007
AP	0	12/3/2007	SLR	18663	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf	12/14/2007
AP	0	12/3/2007	SLR	18864	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021135s017ltr.pdf	1/9/2008
AP	0	6/22/2011	SLR	29303	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021135s020ltr.pdf	6/28/2011
AP	0	6/22/2011	SLR	29349	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf	6/29/2011
AP	0	3/29/2013	SCM	35622	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf	4/1/2013
AP	0	9/21/2012	S	33822	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021135Orig1s024ltr.pdf	9/24/2012
AP	0	9/21/2012	S	33839	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf	9/25/2012
AP	0	3/2/2016	SCM
AP	0	6/13/2014	SCM
AP	0	5/13/2015	SCM
AP	0	6/13/2016	SCM
AP	0	5/27/2016	SCM

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