FDA Drug Application 020207 by APOTEX INC

Application Number	020207
Application Type	New Drug Application
Sponsor Applicant	APOTEX INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/18/1992	N
AP	1/5/1994	SLR
AP	3/3/2000	SCM
AP	10/9/2001	SCM
AP	10/9/2001	SCS
AP	1/7/2002	SLR	3460	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf	1/7/2002
AP	4/29/2003	SLR	5736	007	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20207slr007ltr.pdf	5/29/2003
AP	4/29/2003	SLR	7684	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf	2/6/2004
AP	6/14/2005	SLR	11819	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020207s012ltr.pdf	6/15/2005
AP	6/9/2011	SLR	29124	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf	6/14/2011
AP	6/9/2011	SLR	29128	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf	6/14/2011
AP	5/2/2011	SLR	28686	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf	5/2/2011
AP	5/2/2011	SLR	28691	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020207s017ltr.pdf	5/4/2011

Back to FDA Applications sponsored by APOTEX INC