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FDA Drug Application 021497 by ROMARK

Application Number021497
Application Type New Drug Application
Sponsor ApplicantROMARK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/21/2004N9836000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf 7/21/2004
AP07/21/2004N9843000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf 7/21/2004
AP07/21/2004N10372000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm 10/8/2004
AP07/11/2016SLR46509001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf 7/12/2016
AP07/11/2016SLR46527001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf 7/13/2016
AP012/5/2012SCM       
AP03/3/2015SCM       




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