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FDA Drug Approval Applications Sponsored by SHIRE

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
005795 New Drug Application Approval New formulation (S) Standard review drug
007390 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
008732 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011270 New Drug Application Approval New formulation (S) Standard review drug
011323 New Drug Application Approval New combination (S) Standard review drug
012359 New Drug Application Approval New combination (S) Standard review drug
012892 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016913 New Drug Application Approval New manufacturer (S) Standard review drug
019753 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019836 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020049 New Drug Application Approval New formulation (P) Priority review drug
020712 New Drug Application Approval New formulation (S) Standard review drug
021303 New Drug Application Approval New formulation (S) Standard review drug
022000 New Drug Application Approval New formulation (S) Standard review drug
022037 New Drug Application Approval New formulation (S) Standard review drug
050493 New Drug Application Approval New formulation (S) Standard review drug
083789 Abbreviated New Drug Application Approval
083791 Abbreviated New Drug Application Approval
084051 Abbreviated New Drug Application Approval
087628 Abbreviated New Drug Application Approval
125151 Biologic License Application Approval

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