FDA Drug Application 018554 by SCHERING

Application Number	018554
Application Type	New Drug Application
Sponsor Applicant	SCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/27/1989	N
AP	10/17/1989	SLR
AP	7/29/1992	SCM
AP	9/3/1990	SLR
AP	8/30/1996	SCS
AP	5/7/1991	SCS
AP	7/22/1993	SCM
AP	5/18/1992	SCM
AP	9/19/1991	SLR
AP	10/26/1994	SLR
AP	9/15/1995	SLR
AP	11/15/1995	SCM
AP	6/21/1996	SE1
AP	8/19/1999	SLR
AP	11/12/1997	SCS
AP	5/18/1998	SCS
AP	1/7/2000	SCM
AP	1/23/2001	SCM
AP	3/14/2001	SCS
AP	3/23/2001	SLR	1622	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S21LTR.PDF	3/23/2001
AP	3/23/2001	SLR	11055	021	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S021.pdf	1/28/2005
AP	3/30/2001	SLR	1623	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S22LTR.PDF	3/30/2001
AP	3/30/2001	SLR	11056	022	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S022.pdf	1/28/2005
AP	7/23/2001	SLR	5224	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf	4/14/2003

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