FDA Drug Application 008306 by ANI PHARMS

Application Number	008306
Application Type	New Drug Application
Sponsor Applicant	ANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/21/1952	N
AP	4/2/1984	SCF
AP	4/2/1984	SES
AP	4/12/1984	SPD
AP	5/29/1986	SCS
AP	4/13/1987	SCS
AP	7/29/1985	SCS
AP	11/4/1985	SLR
AP	6/30/1988	SCS
AP	1/11/1989	SLR
AP	12/12/1989	SCM
AP	12/12/1989	SCM
AP	3/30/1992	SCM
AP	2/10/1998	SCS
AP	5/6/1998	SCM
AP	6/23/2000	SCS
AP	2/23/2001	SLR	17066	029	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008306_S029_PHENERGA-CODEINE_AP.pdf	7/6/2007
AP	11/26/2008	SLR	21293	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf	11/28/2008
AP	11/26/2008	SLR	21495	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf	1/2/2009
AP	5/9/2013	SLR	36038	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008306Orig1s031ltr.pdf	5/13/2013
AP	5/9/2013	SLR	36056	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf	5/14/2013

Back to FDA Applications sponsored by ANI PHARMS