FDA Drug Application 008381 by ANI PHARMS

Application Number	008381
Application Type	New Drug Application
Sponsor Applicant	ANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	4/11/1952	N
AP	4/18/1984	SPD
AP	4/18/1984	SCF
AP	4/18/1984	SE1
AP	5/29/1986	SCS
AP	7/27/1985	SCS
AP	11/4/1985	SLR
AP	9/8/1986	SLR
AP	3/2/1987	SLR
AP	4/6/1988	SLR
AP	6/30/1988	SCS
AP	12/13/1989	SCM
AP	12/12/1989	SCM
AP	2/6/1992	SCS
AP	3/30/1992	SCM
AP	5/6/1998	SCM
AP	6/27/2003	S	6029	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf	7/6/2003
AP	6/27/2003	SLR	6028	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf	7/6/2003
AP	4/2/2008	SCM	19630	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf	4/9/2008
AP	4/2/2008	SCM	19660	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf	4/16/2008
AP	11/10/2008	SLR	21206	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf	11/12/2008
AP	11/10/2008	SLR	21219	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf	11/13/2008

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