FDA Drug Application 014879 by EUROHLTH INTL SARL

Application Number	014879
Application Type	New Drug Application
Sponsor Applicant	EUROHLTH INTL SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/23/1965	N
AP	4/5/1976	SLR
AP	11/1/1976	SCS
AP	9/11/1979	SCS
AP	5/3/1976	SCS
AP	4/6/1977	SCS
AP	6/20/1977	SCM
AP	2/15/1979	SCM
AP	2/15/1979	SLR
AP	11/27/1978	SLR
AP	11/30/1978	SCS
AP	2/15/1980	SCS
AP	9/24/1981	SCS
AP	8/6/1982	SCS
AP	8/6/1982	SLR
AP	8/6/1982	SOA
AP	8/6/1982	SLR
AP	3/4/1982	SCM
AP	9/17/1985	SPD
AP	3/2/1983	SCS
AP	5/16/1984	SCS
AP	7/24/1986	SCS
AP	6/18/1986	SCS
AP	1/14/1987	SLR
AP	1/14/1987	SLR
AP	5/31/1988	SCS
AP	1/13/1989	SCS
AP	2/13/1998	SCM
AP	8/23/2001	SLR	1741	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14879s36ltr.pdf	8/23/2001
AP	3/29/2006	SLR	13851	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014879s037ltr.pdf	4/5/2006
AP	4/16/2004	SLR	8386	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf	4/20/2004
AP	4/16/2004	SLR	8474	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf	5/3/2004
AP	3/17/2005	SLR	11281	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14879s044ltr.pdf	3/23/2005
AP	3/17/2005	SLR	11282	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf	3/23/2005
AP	3/17/2005	SLR	17239	044	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/014879_S044_Dopram Injection_APPROVAL_ PACKAGE.pdf	7/9/2007

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