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FDA Drug Application 020489 by ALLERGAN SALES LLC

Application Number020489
Application Type New Drug Application
Sponsor ApplicantALLERGAN SALES LLC
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
AP09/29/1995N       
AP07/10/1996SLR       
AP04/22/1997SCP       
AP05/2/1997SCS3667003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20489-S003_ANDRODERM.PDF 5/2/1997
AP03/18/1998SLR       
AP06/29/1998SCS       
AP010/9/1998SCF       
AP01/15/2002SLR4450007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489s7ltr.pdf 1/15/2002
AP01/15/2002SLR17106007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020489_S007_ANDRODERM_AP.pdf 7/6/2007
AP07/13/2000SCS       
AP010/24/2000SCM       
AP08/9/2002SLR4449010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20489slr010ltr.pdf 8/9/2002
AP011/27/2002SCF       
AP05/19/2006SLR14142013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020489s013lbl.pdf 5/22/2006
AP05/19/2006SLR14161013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020489s013LTR.pdf 5/22/2006
AP010/20/2011SE830402025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020489s025ltr.pdf 10/25/2011
AP010/20/2011SE830418025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020489s025lbl.pdf 10/25/2011
AP04/26/2012SLR32575027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020489s027lbl.pdf 5/1/2012
AP04/26/2012SLR32583027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020489Orig1s027ltr.pdf 5/2/2012
AP01/16/2014SCM       
AP06/19/2014SLR39600031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020489Orig1s031ltr.pdf 6/23/2014
AP06/19/2014SLR39647031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020489s031lbl.pdf 6/23/2014
AP04/30/2015SCM       
AP05/11/2015SLR42795033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020489Orig1s033ltr.pdf 5/13/2015
AP05/11/2015SLR42804033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020489s033lbl.pdf 5/13/2015
AP010/25/2016SLR47473034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020489Orig1s034ltr.pdf 10/27/2016




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