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FDA Drug Application 008453 by SANDOZ

Application Number008453
Application Type New Drug Application
Sponsor ApplicantSANDOZ
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/20/1952N       
AP06/22/1973SFP3712001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf 6/12/2000
AP012/5/1975SLR3717004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf 6/12/2000
AP03/30/1978SCS3718006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf 6/12/2000
AP05/22/1985SCF       
AP011/21/1980SCS       
AP012/22/1981SLR       
AP02/12/1981SCS       
AP05/15/1981SCS       
AP02/11/1982SCP3719012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/8453S1S4S6S12_Anectine.pdf 6/12/2000
AP05/1/1985SLR       
AP011/10/1987SLR       
AP010/29/1993SLR       
AP09/26/2000SLR       
AP011/28/1994SLR       
AP04/10/1997SCM       
AP010/2/2000SLR       
AP011/22/2010SLR27069027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf 11/22/2010
AP011/22/2010SLR27072027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/008453s027ltr.pdf 11/30/2010
AP01/17/2013SCM       
AP01/25/2016SCM       




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