FDA Drug Application 011559 by PAR STERILE PRODUCTS

Application Number	011559
Application Type	New Drug Application
Sponsor Applicant	PAR STERILE PRODUCTS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/27/1960	N
AP	12/11/1969	SLR
AP	6/13/1975	SLR
AP	5/14/1976	SLR
AP	10/4/1979	SCS
AP	7/1/1981	SCS
AP	7/8/1988	SLR
AP	12/18/1992	SLR
AP	12/2/1992	SLR
AP	6/14/1994	SCS
AP	11/2/1995	SCP
AP	2/29/1996	SCM
AP	7/25/1996	SCS
AP	1/30/1998	SE3
AP	1/30/1998	SE3
AP	12/17/1997	SLR
AP	7/13/2001	SLR	4330	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf	7/13/2001
AP	3/14/2003	SCM	8799	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf	5/28/2004
AP	5/27/2004	SLR	8848	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf	6/1/2004
AP	5/27/2004	SLR	8876	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf	6/1/2004
AP	5/5/2008	SLR	19784	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011559s041ltr.pdf	5/8/2008
AP	5/5/2008	SLR	19992	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf	6/12/2008
AP	1/23/2014	SLR	38365	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011559Orig1s045ltr.pdf	1/24/2014
AP	1/23/2014	SLR	38384	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf	1/28/2014
AP	9/22/2014	SCM
AP	12/15/2014	SCM

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