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FDA Drug Application 204150 by ALEMBIC PHARMS LTD

Application Number204150
Application Type New Drug Application
Sponsor ApplicantALEMBIC PHARMS LTD
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
TA012/21/2012TA34851000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf 1/7/2013
AP13/4/2013N34851000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf 1/7/2013
TA012/21/2012TA34867000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf 1/11/2013
AP13/4/2013N34867000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204150Orig1s000TAltr.pdf 1/11/2013
TA012/21/2012TA35338000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf 3/5/2013
AP13/4/2013N35338000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204150Orig1s000ltr.pdf 3/5/2013
TA012/21/2012TA35391000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf 3/8/2013
AP13/4/2013N35391000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204150s000lbl.pdf 3/8/2013
TA012/21/2012TA37221000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150_desvenlafaxine_toc.cfm 9/26/2013
AP13/4/2013N37221000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150_desvenlafaxine_toc.cfm 9/26/2013
TA012/21/2012TA37222000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf 9/26/2013
AP13/4/2013N37222000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204150Orig1s000SumR.pdf 9/26/2013
AP07/7/2014SLR39799001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf 7/8/2014
AP07/7/2014SLR39814001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf 7/9/2014
AP07/7/2014SLR39815002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204150Orig1s001,s002ltr.pdf 7/9/2014
AP07/7/2014SLR39800002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204150s001s002lbl.pdf 7/8/2014
AP05/15/2015SLR42837003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204150Orig1s003ltr.pdf 5/19/2015
AP05/15/2015SLR42870003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204150s003lbl.pdf 5/21/2015
AP09/9/2016SLR47028004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204150s004lbl.pdf 9/12/2016
AP09/9/2016SLR47049004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204150Orig1s004ltr.pdf 9/15/2016




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