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FDA Drug Application 020140 by SPECTRUM PHARMS

Application Number020140
Application Type New Drug Application
Sponsor ApplicantSPECTRUM PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/7/2008N19424000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s000ltrCorrected.pdf 3/12/2008
AP03/7/2008N19442000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140lbl.pdf 3/13/2008
AP03/7/2008N25025000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140_levoleucovorin_toc.cfm 3/11/2010
AP03/7/2008N25026000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020140s000SumR.pdf 3/11/2010
AP07/14/2008SLR20206001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020140s001lbl.pdf 7/15/2008
AP07/14/2008SLR20212001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020140s001ltr.pdf 7/15/2008
AP04/29/2011SE128666002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020140s002lbl.pdf 5/2/2011
AP04/29/2011SE128690002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020140s002ltr.pdf 5/4/2011
AP011/9/2012SCM       
AP06/24/2014SCM       
AP09/15/2016SCM       




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