FDA Drug Application 008453 by SANDOZ

Application Number	008453
Application Type	New Drug Application
Sponsor Applicant	SANDOZ
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	8/20/1952	N
AP	6/22/1973	SFP	3712	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf	6/12/2000
AP	12/5/1975	SLR	3717	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf	6/12/2000
AP	3/30/1978	SCS	3718	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf	6/12/2000
AP	5/22/1985	SCF
AP	11/21/1980	SCS
AP	12/22/1981	SLR
AP	2/12/1981	SCS
AP	5/15/1981	SCS
AP	2/11/1982	SCP	3719	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf	6/12/2000
AP	5/1/1985	SLR
AP	11/10/1987	SLR
AP	10/29/1993	SLR
AP	9/26/2000	SLR
AP	11/28/1994	SLR
AP	4/10/1997	SCM
AP	10/2/2000	SLR
AP	11/22/2010	SLR	27069	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf	11/22/2010
AP	11/22/2010	SLR	27072	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008453s027ltr.pdf	11/30/2010
AP	1/17/2013	SCM
AP	1/25/2016	SCM

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