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FDA Drug Application 021262 by ALLERGAN

Application Number021262
Application Type New Drug Application
Sponsor ApplicantALLERGAN
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
AP03/16/2001N3869000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_Approv.pdf 3/16/2001
AP03/16/2001N3870000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf 3/16/2001
AP03/16/2001N8700000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-262_AlphaganP.cfm 5/27/2004
AP010/23/2001SCM       
AP06/5/2001SCM       
AP010/15/2001SCS       
AP012/18/2001SCS       
AP012/4/2001SCM       
AP012/20/2001SE53867006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490S007_Brimonidine%20Tartrate%20Ophthalmic_Approv.pdf 12/20/2001
AP012/20/2001SE53868006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21262s6lbl.pdf 12/20/2001
AP012/20/2001SE58696006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-490s007_Alphagan.cfm 5/27/2004
AP01/22/2002SCM       
AP06/19/2002SCS       
AP04/12/2002SCM       
AP02/10/2004SCP7753010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf 2/27/2004
AP02/10/2004SLR7754013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21262slcp010,slr013ltr.pdf 2/27/2004
AP05/22/2006SLR14166018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021262s018lbl.pdf 5/24/2006
AP05/22/2006SLR14175018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021262s018LTR.pdf 5/25/2006
AP08/13/2010SLR26220020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021262s020,021770s004ltr.pdf 8/16/2010
AP08/13/2010SLR26301020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf 8/28/2010
AP05/19/2014SCM       




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