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FDA Drug Application 203050 by DR REDDYS LABS LTD

Application Number203050
Application Type New Drug Application
Sponsor ApplicantDR REDDYS LABS 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
TA011/2/2012TA34284000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203050Orig1s000TAltr.pdf 11/6/2012
TA011/2/2012TA45334000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203050Orig1s000ltr.pdf 3/3/2016
TA011/2/2012TA45355000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203050s000lbl.pdf 3/3/2016
AP13/1/2016N34284000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203050Orig1s000TAltr.pdf 11/6/2012
AP13/1/2016N45334000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203050Orig1s000ltr.pdf 3/3/2016
AP13/1/2016N45355000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203050s000lbl.pdf 3/3/2016




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