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FDA Drug Approval Applications Sponsored by ROCHE

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
003718 New Drug Application Approval
006071 New Drug Application Approval
006525 New Drug Application Approval
006917 New Drug Application Approval
007757 New Drug Application Approval New manufacturer (S) Standard review drug
008414 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
008420 New Drug Application Approval New manufacturer (S) Standard review drug
008983 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
009182 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
009660 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
010355 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
010423 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011745 New Drug Application Approval New manufacturer (S) Standard review drug
012486 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
012487 New Drug Application Approval New formulation (S) Standard review drug
012715 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
013263 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
013294 New Drug Application Approval New combination (S) Standard review drug
013664 New Drug Application Approval New manufacturer (S) Standard review drug
014740 New Drug Application Approval New combination (S) Standard review drug
016087 New Drug Application Approval New formulation (S) Standard review drug
016149 New Drug Application Approval New formulation (S) Standard review drug
016912 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017533 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017546 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017589 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017952 New Drug Application Approval New manufacturer (S) Standard review drug
018179 New Drug Application Approval New formulation (S) Standard review drug
018550 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018557 New Drug Application Approval New molecular entity (NME); New combination (P) Priority review drug
019358 New Drug Application Approval New indication (S) Standard review drug
019369 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019591 New Drug Application Approval New manufacturer (S) Standard review drug (V) Orphan drug
020137 New Drug Application Approval New formulation (S) Standard review drug
020199 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug* (V) Orphan drug
020239 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020305 New Drug Application Approval New formulation (S) Standard review drug
020438 New Drug Application Approval New formulation (P) Priority review drug (V) Orphan drug
020813 New Drug Application Approval New formulation (S) Standard review drug
020942 New Drug Application Approval New formulation (P) Priority review drug
021087 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021238 New Drug Application Approval New formulation (S) Standard review drug
021246 New Drug Application Approval New formulation (P) Priority review drug
021481 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021511 New Drug Application Approval New formulation (P) Priority review drug
021858 New Drug Application Approval New formulation (S) Standard review drug
050565 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
062510 Abbreviated New Drug Application Approval
083639 Abbreviated New Drug Application Approval
085303 Abbreviated New Drug Application Approval
085749 Abbreviated New Drug Application Approval

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