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FDA Drug Application 021993 by BAYER HEALTHCARE LLC

Application Number021993
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP012/12/2006N15460000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021993s000lbl.pdf 12/14/2006
AP012/12/2006N15476000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021993s000ltr.pdf 12/14/2006
AP012/12/2006N20927000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021993_claritin_toc.cfm 10/3/2008
AP010/21/2008SLR21075004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021993s004ltr.pdf 10/23/2008
AP07/22/2014SLR39961012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf 7/24/2014
AP07/22/2014SLR40052012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf 7/29/2014
AP011/25/2015SLR44613013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf 11/27/2015
AP011/25/2015SLR44643013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf 12/1/2015




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