FDA Drug Application 007638 by BAYER HEALTHCARE LLC

Application Number	007638
Application Type	New Drug Application
Sponsor Applicant	BAYER HEALTHCARE LLC
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	8/15/1950	N
AP	10/18/1978	SLR
AP	1/5/1979	SCS
AP	12/20/1979	SLR
AP	2/1/1980	SCP
AP	7/3/1980	SCS
AP	7/30/1980	SCS
AP	6/11/1980	SCM
AP	10/30/1981	SLR
AP	5/7/1982	SE6
AP	8/30/1982	SCS
AP	1/4/1983	SLR
AP	2/18/1983	SCS
AP	1/30/1986	SLR
AP	9/18/1984	SCP
AP	1/30/1986	SE6
AP	7/8/1986	SCS
AP	10/20/1997	SLR
AP	11/17/1998	SCS
AP	5/19/2000	SCS
AP	1/26/2001	SCS
AP	3/6/2002	SCE
AP	1/19/2006	SCF	13519	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf	1/30/2006
AP	2/4/2008	SLR	19074	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf	2/7/2008
AP	12/23/2015	SCM	44892	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/007638Orig1s038ltr.pdf	12/29/2015

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