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FDA Drug Application 021598 by ALCON PHARMS LTD

Application Number021598
Application Type New Drug Application
Sponsor ApplicantALCON PHARMS LTD
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
AP04/15/2003N5366000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598_vigamox_lbl.pdf 4/17/2003
AP04/15/2003N5694000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598ltr.pdf 5/29/2003
AP04/15/2003N11360000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-598_Vigamox.cfm 4/8/2005
AP010/3/2003SCP6788001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf 10/10/2003
AP010/3/2003SCP6767001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf 10/3/2003
AP04/12/2004SLR8355002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf 4/20/2004
AP04/12/2004SLR8461002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr002_vigamox_lbl.pdf 5/3/2004
AP010/3/2003SLR6768005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf 10/3/2003
AP010/3/2003SLR6789005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21598scp001,slr005_vigamox_lbl.pdf 10/10/2003
AP06/25/2004SLR9688008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf 7/1/2004
AP06/25/2004SLR9698008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21598slr008_vigamox_lbl.pdf 7/1/2004
AP010/7/2011SLR30247017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021598s017ltr.pdf 10/12/2011
AP010/7/2011SLR30252017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021598s017lbl.pdf 10/12/2011
AP09/6/2016SCM       




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