Back to FDA Applications sponsored by NOVARTIS

FDA Drug Application 020254 by NOVARTIS

Application Number	020254
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
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	3/8/1996	N
AP	5/21/1996	SCM
AP	10/31/2001	SLR
AP	3/11/1997	SCS
AP	5/16/1997	SCM
AP	4/22/1999	SCP
AP	2/18/2000	SCM
AP	9/20/2000	SCM
AP	12/13/2000	SCS
AP	10/23/2000	SCM
AP	9/28/2001	SCS
AP	11/5/2001	SCS
AP	3/11/2002	SCM
AP	9/19/2002	SCS
AP	1/24/2006	SLR	13478	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf	1/25/2006
AP	1/24/2006	SLR	13539	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf	1/30/2006
AP	1/24/2006	SLR	44392	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020254Orig1s016.pdf	11/5/2015
AP	2/25/2009	SLR	21919	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf	2/27/2009
AP	2/25/2009	SLR	22017	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf	3/17/2009
AP	2/23/2011	SLR	27979	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28044	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf	3/4/2011
AP	2/23/2011	SLR	27982	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28045	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf	3/4/2011
AP	1/25/2013	SCM
AP	2/28/2014	SCM
AP	6/5/2014	SCM
AP	5/9/2016	SLR	45967	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf	5/11/2016
AP	5/9/2016	SLR	46005	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf	5/12/2016
AP	5/9/2016	SLR	46055	028	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501669.pdf	5/18/2016

Back to FDA Applications sponsored by NOVARTIS