FDA Drug Application 050665 by CORDEN PHARMA

Application Number	050665
Application Type	New Drug Application
Sponsor Applicant	CORDEN PHARMA
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	12/23/1991	N
AP	12/31/1992	SE5
AP	5/17/1995	SE5
AP	12/7/1993	SCF
AP	12/7/1993	SCP
AP	8/31/1995	SLR
AP	8/31/1995	SLR
AP	4/10/1995	SCS
AP	2/8/1995	SLR
AP	5/9/1995	SLR
AP	12/26/1995	SLR	9244	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf	6/9/2004
AP	9/5/1996	SE1
AP	2/7/1996	SCS
AP	8/26/1997	SLR
AP	4/23/1997	SLR
AP	5/29/1997	SLR
AP	1/5/1998	SCM
AP	9/8/1998	SCS
AP	5/13/1999	SCP
AP	4/15/1999	SCP
AP	10/1/2001	SLR
AP	6/23/2004	N	9537	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf	6/25/2004
AP	6/23/2004	N	9558	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf	6/25/2004
AP	9/14/2007	SLR	17899	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	9/19/2007
AP	9/14/2007	SLR	17988	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf	9/25/2007

Back to FDA Applications sponsored by CORDEN PHARMA