FDA Drug Application 020038 by GENZYME CORP

Application Number	020038
Application Type	New Drug Application
Sponsor Applicant	GENZYME CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	4/18/1991	N
AP	12/4/1991	SCS
AP	12/4/1991	SCS
AP	4/2/1992	SLR
AP	1/7/1993	SCS
AP	1/7/1993	SCM
AP	10/28/1992	SLR
AP	5/21/1993	SCM
AP	9/26/1994	SLR
AP	1/29/1996	SCS
AP	5/24/1999	SLR
AP	9/5/1996	SCS
AP	12/3/2001	SLR	5394	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20038s19lbl.pdf	4/21/2003
AP	3/8/2000	SCP
AP	7/2/2002	SCM
AP	7/2/2002	SCS
AP	3/28/2002	SCS
AP	5/1/2002	SCM
AP	5/1/2002	SCS
AP	8/1/2003	SE8	6490	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20038se8-028_fludara_lbl.pdf	8/14/2003
AP	8/1/2003	SE8	6495	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20038se8-028ltr.pdf	8/14/2003
AP	12/20/2007	SLR	18674	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf	12/27/2007
AP	12/20/2007	SLR	18815	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020038s031ltr.pdf	1/9/2008
AP	2/10/2009	SLR	21813	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf	2/12/2009
AP	2/10/2009	SLR	21830	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020038s032ltr.pdf	2/13/2009
AP	7/29/2010	SLR	26071	033	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020038s033lbl.pdf	7/31/2010
AP	7/29/2010	SLR	26085	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020038s033ltr.pdf	8/2/2010

Back to FDA Applications sponsored by GENZYME CORP