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FDA Drug Approval Applications Sponsored by MONARCH PHARMS

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
009818 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017376 New Drug Application Approval New molecular entity (NME); New combination (P) Priority review drug
017598 New Drug Application Approval New manufacturer (S) Standard review drug
017943 New Drug Application Approval New formulation (S) Standard review drug
018299 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
018452 New Drug Application Approval New manufacturer (S) Standard review drug
050168 New Drug Application Approval
050169 New Drug Application Approval
050218 New Drug Application Approval
050479 New Drug Application Approval New manufacturer (S) Standard review drug
060582 Abbreviated New Drug Application Approval
060707 Abbreviated New Drug Application Approval
061229 Abbreviated New Drug Application Approval
062822 Abbreviated New Drug Application Approval
083011 Abbreviated New Drug Application Approval
084948 Abbreviated New Drug Application Approval
084949 Abbreviated New Drug Application Approval
084950 Abbreviated New Drug Application Approval
084951 Abbreviated New Drug Application Approval
087563 Abbreviated New Drug Application Approval
088051 Abbreviated New Drug Application Approval
088656 Abbreviated New Drug Application Approval

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