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FDA Drug Application 050790 by ALLERGAN

Application Number050790
Application Type New Drug Application
Sponsor ApplicantALLERGAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/2002N6592000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf 9/8/2003
AP012/23/2002N6593000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050790lbl.pdf 9/8/2003
AP012/23/2002N11404000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-023_Restasis.cfm 4/14/2005
AP09/16/2003SLR6674001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790slr001ltr.pdf 9/25/2003
AP09/16/2003SLR6697001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50790slr001_restasis_lbl.pdf 9/26/2003
AP09/12/2003SCM16740002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050790_S002_RestasisTOC.cfm 6/11/2007
AP010/1/2003SCP6770003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf 10/1/2003
AP010/1/2003SLR6771004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf 10/1/2003
AP01/16/2013SCM       
AP012/3/2012SLR34529020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf 12/4/2012
AP012/3/2012SLR34551020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050790Orig1s020ltr.pdf 12/5/2012
AP05/31/2013SCM36208021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050790s021lbl.pdf 6/4/2013
AP01/16/2014SCM       
AP11/28/2014SCM       
AP012/5/2013SCM       




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