FDA Drug Application 018713 by BAYER HLTHCARE

Application Number	018713
Application Type	New Drug Application
Sponsor Applicant	BAYER HLTHCARE
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	6/17/1983	N
AP	11/13/1984	SCS
AP	9/11/1985	SLR
AP	6/3/1987	SCM	16999	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018713_S004_MYCELEX TROCHE_AP.pdf	7/6/2007
AP	1/27/1988	SCS
AP	1/15/1988	SCE
AP	9/29/1992	SE1
AP	12/7/1988	SCS
AP	9/15/1989	SCP
AP	1/18/1990	SCS
AP	12/30/1991	SLR
AP	6/30/1999	SCS
AP	10/7/1999	SCM	17000	014	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018713_S014_MYCELEX TROCHE_AP.pdf	7/6/2007
AP	1/23/2001	SCS
AP	3/26/2001	SCM	17001	017	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018713_S017_MYCELEX TROCHE_AP.pdf	7/6/2007
AP	12/15/2002	SLR	3654	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18713slr019ltr.pdf	12/15/2002
AP	12/15/2002	SLR	3655	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18713slr019_mycelex_lbl.pdf	12/15/2002

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