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FDA Drug Application 021665 by AMPHASTAR PHARM

Application Number021665
Application Type New Drug Application
Sponsor ApplicantAMPHASTAR PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/2004N10501000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf 10/29/2004
AP010/26/2004N10523000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf 11/1/2004
AP010/26/2004N11083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-665_Amphadase.cfm 2/4/2005
AP011/3/2005SLR13033001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf 11/8/2005
AP011/3/2005SLR13043001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf 11/8/2005
AP011/3/2005SCS13034002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf 11/8/2005
AP011/3/2005SCS13044002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf 11/8/2005
AP06/28/2012SLR33062005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf 6/29/2012
AP06/28/2012SLR33066005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021665s005ltr.pdf 6/29/2012
AP06/19/2015SCM       




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