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FDA Drug Approval Applications Sponsored by SEBELA IRELAND LTD

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
016084 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016324 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017391 New Drug Application Approval New formulation (P) Priority review drug
017744 New Drug Application Approval New molecular entity (NME); New combination (S) Standard review drug
018689 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019425 New Drug Application Approval New manufacturer (S) Standard review drug
021107 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021299 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
040396 Abbreviated New Drug Application Approval
040398 Abbreviated New Drug Application Approval
050719 New Drug Application Approval New combination (S) Standard review drug
083778 Abbreviated New Drug Application Approval
085368 Abbreviated New Drug Application Approval
085979 Abbreviated New Drug Application Approval
085980 Abbreviated New Drug Application Approval
204516 New Drug Application Approval New formulation (S) Standard review drug

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