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FDA Drug Approval Applications Sponsored by GLAXOSMITHKLINE LLC

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
016042 New Drug Application Approval New combination (S) Standard review drug
018118 New Drug Application Approval New formulation (S) Standard review drug
019151 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020241 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020259 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug* (V) Orphan drug
020336 New Drug Application Approval New formulation (S) Standard review drug
020444 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020500 New Drug Application Approval New formulation (P) Priority review drug
020658 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020763 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020764 New Drug Application Approval New formulation (S) Standard review drug
021416 New Drug Application Approval New formulation (S) Standard review drug
021438 New Drug Application Approval New manufacturer (S) Standard review drug
022008 New Drug Application Approval New formulation (S) Standard review drug
022115 New Drug Application Approval New formulation (S) Standard review drug
022251 New Drug Application Approval New formulation (S) Standard review drug
125431 Biologic License Application Approval
125526 Biologic License Application Approval

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