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FDA Drug Application 019941 by ACTAVIS LABS UT INC

Application Number019941
Application Type New Drug Application
Sponsor ApplicantACTAVIS LABS UT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1992N       
AP04/11/1994SLR18629002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019941_S002_EMLA_CREAM.pdf 12/6/2007
AP09/27/1995SCM       
AP05/31/1996SCM       
AP05/31/1996SCM       
AP02/4/1998SLR145007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf 2/4/1998
AP02/4/1998SE4261008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf 2/4/1998
AP02/4/1998SLR427009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf 2/4/1998
AP03/11/1999SE8913010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19941s10ltr.pdf 3/11/1999
AP01/28/2000SE11258011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19941S11LTR.PDF 1/28/2000
AP01/28/2000SE11259011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF 1/28/2000
AP01/28/2000SE18035011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-941S011.pdf 3/24/2004
AP04/20/2000SLR18630012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019941_S012_EMLA_CREAM.pdf 12/6/2007
AP06/2/2000SCS       
AP01/27/2003SCP8945015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19941scp014,015ltr.pdf 6/3/2004
AP012/19/2005SLR13328017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf 1/5/2006
AP012/19/2005SLR13403017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019941s017ltr.pdf 1/19/2006
AP012/19/2005SLR18631017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019941_S017_EMLA_CREAM.pdf 12/6/2007
AP04/27/2006SLR13997018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf 5/1/2006
AP04/27/2006SLR14023018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019941s018LTR.pdf 5/1/2006
AP01/25/2013SCM       




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