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FDA Drug Application 018827 by MERCK SHARP DOHME

Application Number	018827
Application Type	New Drug Application
Sponsor Applicant	MERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	7/10/1984	N
AP	2/22/1985	SCP
AP	4/23/1986	SCM
AP	5/20/1986	SCS
AP	9/12/1986	SCM
AP	10/29/1987	SCM
AP	8/1/1990	SCS
AP	10/3/2001	SLR	5255	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf	4/15/2003
AP	9/11/1990	SCS
AP	10/3/2001	SLR
AP	10/6/1994	SCP
AP	1/30/1995	SCM
AP	1/30/1995	SCS
AP	6/15/1998	SCS
AP	7/31/1998	SCS
AP	5/18/1998	SCS
AP	11/10/1998	SCP
AP	5/14/1999	SCS
AP	2/2/2000	SCS
AP	10/3/2001	SLR
AP	2/28/2001	SCS
AP	10/3/2001	SE5	6278	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf	7/31/2003
AP	10/3/2001	SE5	12391	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf	7/29/2005
AP	1/10/2002	SCS
AP	3/27/2003	SLR	4646	025	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf	3/28/2003
AP	3/27/2003	SLR	5275	025	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf	4/15/2003
AP	1/25/2008	SLR	18963	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf	1/29/2008
AP	1/25/2008	SLR	18969	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf	1/30/2008
AP	5/11/2009	SLR	22567	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf	5/13/2009
AP	5/11/2009	SLR	22890	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf	7/8/2009
AP	4/21/2014	SLR	39111	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf	4/22/2014
AP	4/21/2014	SLR	39118	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf	4/22/2014

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