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FDA Drug Application 075547 by WEST-WARD PHARMS INT

Application Number075547
Application Type Abbreviated New Drug Application
Sponsor ApplicantWEST-WARD PHARMS INT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/2/2001N1181000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75547ltr.pdf 4/2/2001
AP04/2/2001N3904000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa.cfm 12/17/2001
AP04/2/2001N5117000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-547_Thiotepa_prntlbl.pdf 4/2/2001
AP07/8/2015SLR43524006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/075547Orig1s006lbl.pdf 7/30/2015
AP07/8/2015SLR43527006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/075547Orig1s006ltr.pdf 7/30/2015




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