FDA Drug Application 016087 by ROCHE

Application Number	016087
Application Type	New Drug Application
Sponsor Applicant	ROCHE
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	8/24/1966	N
AP	6/20/1974	SLR
AP	6/5/1974	SLR
AP	11/15/1974	SCS
AP	12/2/1974	SCS
AP	5/1/1975	SCS
AP	11/13/1975	SCS
AP	4/23/1976	SCP
AP	7/23/1976	SCF
AP	10/18/1977	SCP
AP	10/24/1978	SCS
AP	3/15/1980	SCS
AP	3/23/1979	SLR
AP	4/9/1979	SCM
AP	5/31/1979	SLR
AP	11/2/1979	SLR
AP	7/20/1979	SLR
AP	5/19/1980	SLR
AP	4/20/1981	SCM
AP	4/16/1981	SCM
AP	3/26/1981	SLR
AP	4/16/1981	SCS
AP	8/24/1981	SCP
AP	11/13/1981	SLR
AP	11/12/1981	SLR
AP	11/19/1981	SCP
AP	8/5/1982	SLR
AP	5/18/1982	SCS
AP	10/27/1982	SCM
AP	8/20/1982	SCS
AP	10/29/1982	SCS
AP	3/1/1983	SCM
AP	4/6/1983	SLR
AP	3/14/1983	SLR
AP	3/14/1983	SLR
AP	3/14/1983	SLR
AP	3/29/1983	SCS
AP	4/18/1983	SCP
AP	6/26/1985	SCS
AP	6/26/1985	SCS
AP	5/31/1985	SCM
AP	6/27/1985	SLR
AP	8/6/1985	SCM
AP	1/15/1986	SCP
AP	6/16/1986	SCP
AP	6/16/1986	SCS
AP	10/29/1986	SCS
AP	10/27/1987	SCS
AP	4/23/1987	SCS
AP	2/7/2002	SLR	2091	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf	2/7/2002
AP	5/25/1993	SCS
AP	2/7/2002	SLR	2094	081	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf	2/7/2002
AP	11/5/1997	SCM
AP	9/17/1997	SCS
AP	9/4/1998	SCS

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