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FDA Drug Application 205703 by HQ SPCLT PHARMA

Application Number205703
Application Type New Drug Application
Sponsor ApplicantHQ SPCLT PHARMA
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
TA04/14/2014TA39046000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205703Orig1s000ltr.pdf 4/16/2014
AP14/7/2016N39046000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205703Orig1s000ltr.pdf 4/16/2014
TA04/14/2014TA45625000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205703s000lbl.pdf 4/8/2016
AP14/7/2016N45625000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205703s000lbl.pdf 4/8/2016
TA04/14/2014TA45628000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205703Orig1s000ltr.pdf 4/11/2016
AP14/7/2016N45628000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205703Orig1s000ltr.pdf 4/11/2016
TA04/14/2014TA47420000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000TOC.cfm 10/20/2016
AP14/7/2016N47420000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000TOC.cfm 10/20/2016




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