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FDA Drug Application 203551 by ACTAVIS INC

Application Number203551
Application Type New Drug Application
Sponsor ApplicantACTAVIS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/12/2013N35701000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000ltr.pdf 4/16/2013
AP04/12/2013N35969000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551Orig1s000lbledt.pdf 5/7/2013
AP04/12/2013N37474000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551_docetaxel_toc.cfm 10/21/2013
AP04/12/2013N37476000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000SumR.pdf 10/21/2013
AP011/4/2013SLR37684001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s001lbl.pdf 11/4/2013
AP011/4/2013SLR37726001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203551Orig1s001ltr.pdf 11/7/2013
AP09/17/2014SLR40528002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203551s002lbl.pdf 9/19/2014
AP09/17/2014SLR40551002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203551Orig1s002ltr.pdf 9/23/2014
AP04/7/2015SCM       
AP09/21/2015SCM       




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