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FDA Drug Application 079075 by WATSON LABS

Application Number079075
Application Type Abbreviated New Drug Application
Sponsor ApplicantWATSON LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA06/22/2010TA25823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf 6/24/2010
AP11/7/2011N25823000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079075s000ltr.pdf 6/24/2010
TA06/22/2010TA27534000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf 1/14/2011
AP11/7/2011N27534000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079075s000ltr.pdf 1/14/2011
TA06/22/2010TA36075000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/079075Orig1s000.pdf 5/15/2013
AP11/7/2011N36075000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/079075Orig1s000.pdf 5/15/2013
TA06/22/2010TA44953000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 1/11/2016
AP11/7/2011N44953000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 1/11/2016




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