FDA Drug Application 010841 by RECORDATI RARE

Application Number	010841
Application Type	New Drug Application
Sponsor Applicant	RECORDATI RARE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	4/22/1957	N
AP	2/5/1980	SCS
AP	7/12/1982	SCP
AP	11/4/1982	SCS
AP	10/28/1983	SCM
AP	11/13/1984	SCS
AP	9/26/2003	SLR	6729	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf	10/1/2003
AP	9/26/2003	SLR	6730	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf	10/1/2003
AP	5/13/1998	SCP
AP	4/4/2002	SCM
AP	12/10/2002	SCS
AP	2/2/2007	SLR	15799	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010841s020LTR.pdf	2/12/2007
AP	2/2/2007	SLR	15852	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf	2/21/2007
AP	4/23/2009	SLR	22343	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf	4/28/2009
AP	4/23/2009	SLR	22354	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010841s021ltr.pdf	4/29/2009
AP	6/7/2010	SLR	25727	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf	6/14/2010
AP	6/7/2010	SLR	25729	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010841s022ltr.pdf	6/14/2010
AP	6/7/2010	SLR	25774	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf	6/24/2010
AP	5/31/2011	SLR	29017	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010841s023ltr.pdf	6/2/2011
AP	1/23/2013	SCM

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