FDA Drug Application 011265 by ANI PHARMS

Application Number	011265
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	12/3/1957	N
AP	4/2/1984	SCF
AP	4/2/1984	SES
AP	4/11/1984	SPD
AP	5/29/1986	SCS
AP	7/31/1985	SCS
AP	9/16/1985	SLR
AP	8/11/1988	SE6
AP	6/30/1988	SCS
AP	11/16/1989	SCM
AP	3/30/1992	SCM
AP	2/27/1996	SLR
AP	5/6/1998	SCM
AP	2/23/2001	SLR	17065	027	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/011265_S027_PHERGAN_AP.pdf	7/6/2007
AP	1/16/2004	SLR	7576	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11265slr028ltr.pdf	1/22/2004
AP	4/2/2008	SCM	19631	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf	4/9/2008
AP	4/2/2008	SCM	19661	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf	4/16/2008
AP	9/16/2009	SLR	23752	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011265s031ltr.pdf	11/9/2009

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