FDA Drug Application 021627 by FOREST LABS LLC

Application Number	021627
Application Type	New Drug Application
Sponsor Applicant	FOREST LABS LLC
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	4/18/2005	N	11437	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021627ltr.pdf	4/19/2005
AP	4/18/2005	N	11438	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021627lbl.pdf	4/19/2005
AP	4/18/2005	N	15134	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021627s000_NamendaTOC.cfm	10/18/2006
AP	10/4/2006	SLR	15096	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf	10/13/2006
AP	4/19/2006	SLR	13971	002	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf	4/21/2006
AP	10/24/2013	SLR	37570	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf	10/25/2013
AP	10/24/2013	SLR	37577	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf	10/25/2013
AP	7/10/2014	SCM
AP	8/11/2014	SLR	40202	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021627Orig1s012ltr.pdf	8/12/2014
AP	8/11/2014	SLR	40213	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021627s012lbl.pdf	8/12/2014

Back to FDA Applications sponsored by FOREST LABS LLC