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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 11/22/2002
AP011/22/2002N3458000 11/22/2002
AP011/22/2002N5483000 4/25/2003
AP07/21/2004S9837001,21498s001ltr.pdf 7/21/2004
AP07/21/2004S9844001,21498s001lbl.pdf 7/21/2004
AP07/21/2004S10373001 10/8/2004
AP06/16/2005SE511828003 6/16/2005
AP06/16/2005SE511841003 6/21/2005
AP06/16/2005SE518114003 10/2/2007
AP07/11/2016SLR46510004,021498Orig1s004ltr.pdf 7/12/2016
AP07/11/2016SLR46528004,021498s004lbl.pdf 7/13/2016

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