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FDA Drug Approval Applications Sponsored by SANOFI AVENTIS US

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
006002 New Drug Application Approval
006327 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
006328 New Drug Application Approval
006412 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
006882 New Drug Application Approval
007504 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
008102 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
008316 New Drug Application Approval New manufacturer (S) Standard review drug
008402 New Drug Application Approval
008682 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
008767 New Drug Application Approval New manufacturer (S) Standard review drug
009166 New Drug Application Approval New formulation (S) Standard review drug
009410 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
009519 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
010155 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
010598 New Drug Application Approval New combination (S) Standard review drug
010679 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
010787 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug
011178 New Drug Application Approval New manufacturer (S) Standard review drug
011444 New Drug Application Approval New combination (S) Standard review drug
011467 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011836 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
012283 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
012339 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
012594 New Drug Application Approval New manufacturer (S) Standard review drug
012972 New Drug Application Approval New combination (S) Standard review drug
013621 New Drug Application Approval New manufacturer (S) Standard review drug
014214 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
014860 New Drug Application Approval New combination (P) Priority review drug
015103 New Drug Application Approval New combination (S) Standard review drug
016131 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016235 New Drug Application Approval New manufacturer (S) Standard review drug
016363 New Drug Application Approval New formulation (P) Priority review drug
016732 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug
016809 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
016830 New Drug Application Approval New formulation (S) Standard review drug
016891 New Drug Application Approval New combination (S) Standard review drug
016990 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017430 New Drug Application Approval New formulation (S) Standard review drug
017446 New Drug Application Approval New manufacturer (S) Standard review drug
017466 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017497 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017532 New Drug Application Approval New manufacturer (S) Standard review drug
017535 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017557 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017603 New Drug Application Approval New formulation (S) Standard review drug
017618 New Drug Application Approval New formulation (S) Standard review drug
017657 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017668 New Drug Application Approval New formulation (S) Standard review drug
017669 New Drug Application Approval New manufacturer (S) Standard review drug
017688 New Drug Application Approval New formulation (S) Standard review drug
017769 New Drug Application Approval New formulation (S) Standard review drug
017796 New Drug Application Approval New manufacturer (S) Standard review drug
017884 New Drug Application Approval New manufacturer (S) Standard review drug
018000 New Drug Application Approval New formulation (S) Standard review drug
018237 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
018458 New Drug Application Approval New combination (S) Standard review drug
018538 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018621 New Drug Application Approval
018685 New Drug Application Approval New combination (S) Standard review drug
018700 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018733 New Drug Application Approval New combination (P) Priority review drug
018770 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019436 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019498 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
019507 New Drug Application Approval New formulation (S) Standard review drug
019548 New Drug Application Approval New formulation (S) Standard review drug
019616 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019798 New Drug Application Approval New formulation (S) Standard review drug
019807 New Drug Application Approval New combination (S) Standard review drug
019879 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
019908 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020055 New Drug Application Approval New formulation (S) Standard review drug
020164 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020165 New Drug Application Approval New formulation (S) Standard review drug
020343 New Drug Application Approval New formulation (S) Standard review drug
020449 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020468 New Drug Application Approval New formulation (P) Priority review drug
020496 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020625 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020707 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020750 New Drug Application Approval New formulation (S) Standard review drug
020757 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020758 New Drug Application Approval New combination (S) Standard review drug
020784 New Drug Application Approval New formulation (S) Standard review drug
020786 New Drug Application Approval New combination (S) Standard review drug
020839 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020872 New Drug Application Approval New formulation (S) Standard review drug
020905 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020955 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021024 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug* (V) Orphan drug
021081 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021144 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021492 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021629 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021704 New Drug Application Approval New formulation (S) Standard review drug
021759 New Drug Application Approval New manufacturer (S) Standard review drug
021774 New Drug Application Approval New formulation (S) Standard review drug
021909 New Drug Application Approval New formulation (S) Standard review drug
021963 New Drug Application Approval New formulation (S) Standard review drug
022138 New Drug Application Approval New indication (P) Priority review drug
022273 New Drug Application Approval New manufacturer (S) Standard review drug (V) Orphan drug
022425 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
050420 New Drug Application Approval
050627 New Drug Application Approval New formulation (S) Standard review drug (V) Orphan drug
050705 New Drug Application Approval New combination (S) Standard review drug (V) Orphan drug
061596 Abbreviated New Drug Application Approval
061613 Abbreviated New Drug Application Approval
061876 Abbreviated New Drug Application Approval
061884 Abbreviated New Drug Application Approval
062303 Abbreviated New Drug Application Approval
062659 Abbreviated New Drug Application Approval
071159 Abbreviated New Drug Application Approval
080564 Abbreviated New Drug Application Approval
083459 Abbreviated New Drug Application Approval
083517
DV
Abbreviated New Drug Application Approval
083518
DV
Abbreviated New Drug Application Approval
083823 Abbreviated New Drug Application Approval
085187 Abbreviated New Drug Application Approval
085202 Abbreviated New Drug Application Approval
085203 Abbreviated New Drug Application Approval
085204 Abbreviated New Drug Application Approval
085205 Abbreviated New Drug Application Approval
085206 Abbreviated New Drug Application Approval
085264 Abbreviated New Drug Application Approval
087091 Abbreviated New Drug Application Approval
087260 Abbreviated New Drug Application Approval
087892 Abbreviated New Drug Application Approval
087893 Abbreviated New Drug Application Approval
087894 Abbreviated New Drug Application Approval
088269 Abbreviated New Drug Application Approval
088746 Abbreviated New Drug Application Approval
089539 Abbreviated New Drug Application Approval
089540 Abbreviated New Drug Application Approval
125418 Biologic License Application Approval
201023 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
201373 New Drug Application Approval OTC (over-the-counter) switch (S) Standard review drug
202992 New Drug Application Approval New molecular entity (NME) (S) Standard review drug

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