FDA Drug Application 020140 by SPECTRUM PHARMS

Application Number	020140
Application Type	New Drug Application
Sponsor Applicant	SPECTRUM PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/7/2008	N	19424	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s000ltrCorrected.pdf	3/12/2008
AP	3/7/2008	N	19442	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf	3/13/2008
AP	3/7/2008	N	25025	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140_levoleucovorin_toc.cfm	3/11/2010
AP	3/7/2008	N	25026	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140s000SumR.pdf	3/11/2010
AP	7/14/2008	SLR	20206	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf	7/15/2008
AP	7/14/2008	SLR	20212	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s001ltr.pdf	7/15/2008
AP	4/29/2011	SE1	28666	002	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf	5/2/2011
AP	4/29/2011	SE1	28690	002	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020140s002ltr.pdf	5/4/2011
AP	11/9/2012	SCM
AP	6/24/2014	SCM
AP	9/15/2016	SCM

Back to FDA Applications sponsored by SPECTRUM PHARMS