FDA Drug Application 050536 by MAYNE PHARMA

Application Number	050536
Application Type	New Drug Application
Sponsor Applicant	MAYNE PHARMA
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	1/26/1981	N
AP	4/22/1981	SCM
AP	5/21/1981	SLR
AP	5/18/1981	SCS
AP	5/20/1981	SCS
AP	6/5/1981	SLR
AP	6/16/1986	SCF
AP	6/5/1981	SCS
AP	6/15/1981	SLR
AP	8/7/1981	SLR
AP	1/28/1982	SCM
AP	3/30/1982	SCE
AP	9/22/2000	SLR
AP	10/21/1997	SCS
AP	8/5/1999	SCS
AP	2/2/2004	SLR	7738	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50536slr016ltr.pdf	2/27/2004
AP	12/18/2003	SLR	7304	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50536slr018ltr.pdf	12/22/2003
AP	1/12/2006	SLR	13391	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050536s019lbl.pdf	1/13/2006
AP	1/12/2006	SLR	13460	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050536s019ltr.pdf	1/20/2006
AP	2/21/2008	SLR	19280	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf	2/25/2008
AP	2/21/2008	SLR	19295	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050536s020ltr.pdf	2/25/2008
AP	3/20/2013	SLR	35498	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050536Orig1s021ltr_corrected.pdf	3/22/2013
AP	3/20/2013	SLR	35535	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050536s021lbl.pdf	3/26/2013
AP	2/14/2012	SLR	31833	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050536s022lbl.pdf	2/17/2012
AP	2/14/2012	SLR	31836	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050536s022ltr.pdf	2/21/2012
AP	12/19/2013	SCM
AP	12/19/2013	SCM

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