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FDA Drug Application 103691 by OMJ PHARMACEUTICALS

Application Number103691
Application Type Biologic License Application
Sponsor ApplicantOMJ PHARMACEUTICALS
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
AP012/16/1997N78990000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/becaomj121697L.htm 3/11/2004
AP012/16/1997N79000000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf 3/11/2004
AP012/16/1997N79010000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080740.htm 3/11/2004
AP012/16/1997N79020000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm072148.htm 3/11/2004
AP05/18/2005S116775015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103691s5015ltr.pdf 5/20/2005
AP05/18/2005S116845015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf 5/20/2005
AP05/18/2005S317885015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103691Orig1s5015Approv.pdf 2/14/2012
AP010/16/2008S210585074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103691s5074ltr.pdf 10/23/2008
AP010/16/2008S235255074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf 10/2/2009
AP03/11/2011S283015095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf 3/21/2011
AP04/30/2012N326035109   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103691s5109ltr.pdf 5/3/2012




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