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FDA Drug Application 021498 by ROMARK

Application Number021498
Application Type New Drug Application
Sponsor ApplicantROMARK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/22/2002N3457000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21498ltr.pdf 11/22/2002
AP011/22/2002N3458000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21498_Alinia_lbl.pdf 11/22/2002
AP011/22/2002N5483000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-498_Alinia.cfm 4/25/2003
AP07/21/2004S9837001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf 7/21/2004
AP07/21/2004S9844001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf 7/21/2004
AP07/21/2004S10373001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm 10/8/2004
AP06/16/2005SE511828003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021498s003lbl.pdf 6/16/2005
AP06/16/2005SE511841003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021498s003ltr.pdf 6/21/2005
AP06/16/2005SE518114003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm 10/2/2007
AP07/11/2016SLR46510004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf 7/12/2016
AP07/11/2016SLR46528004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf 7/13/2016
AP07/25/2014SCM       
AP09/29/2014SCM       




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