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FDA Drug Application 021275 by ALLERGAN

Application Number021275
Application Type New Drug Application
Sponsor ApplicantALLERGAN
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
AP03/16/2001N1565000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21275lbl.pdf 3/16/2001
AP03/16/2001N2751000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan.cfm 8/20/2001
AP03/16/2001N9185000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan0.03percentOpthalmisSolution_approv.pdf 6/8/2004
AP08/7/2001SCM       
AP04/17/2002SCP       
AP04/12/2002SCS       
AP08/26/2002SLR2752006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21275slr006ltr.pdf 8/26/2002
AP08/26/2002SLR2753006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21275s6lbl.pdf 8/26/2002
AP08/25/2003SCP6561010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf 8/28/2003
AP08/25/2003SCP6562010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf 8/28/2003
AP03/11/2011SLR28498011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s011lbl.pdf 3/11/2011
AP08/25/2003SLR6563012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scp010,slr012_lumigan_lbl.pdf 8/28/2003
AP08/25/2003SLR6564012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scp010,slr012ltr.pdf 8/28/2003
AP06/22/2006SE114363013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021275s013LTR.pdf 6/28/2006
AP06/22/2006SE114385013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021275s013lbl.pdf 6/28/2006
AP06/22/2006SE120330013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021275_S013_LUMIGAN.pdf 7/30/2008
AP011/10/2003SCS6957014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf 11/25/2003
AP011/10/2003SCS7042014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf 12/2/2003
AP011/10/2003SLR6958015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21275scs014,slr015ltr.pdf 11/25/2003
AP011/10/2003SLR7041015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21275scs014,slr015_lumigan_lbl.pdf 12/2/2003
AP03/11/2011SLR28491022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021275s022lbl.pdf 2/8/2011
AP03/15/2012SLR32139023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021275s023lbl.pdf 3/16/2012
AP03/15/2012SLR32148023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021275Orig1s023ltr.pdf 3/19/2012
AP02/28/2013SCM       
AP09/29/2014SLR40670026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021275s026lbl.pdf 9/30/2014
AP09/29/2014SLR40687026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021275Orig1s026ltr.pdf 10/2/2014




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