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FDA Drug Approval Applications Sponsored by ROXANE

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
006134 New Drug Application Approval
017058 New Drug Application Approval New manufacturer (S) Standard review drug
017109 New Drug Application Approval New manufacturer (S) Standard review drug
017812 New Drug Application Approval New manufacturer (S) Standard review drug
018421 New Drug Application Approval New manufacturer (S) Standard review drug
018551 New Drug Application Approval
018558 New Drug Application Approval
018823 New Drug Application Approval
020315 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020932 New Drug Application Approval New formulation (S) Standard review drug
021648 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
022195 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
022207 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
022402 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
040032 Abbreviated New Drug Application Approval
040054 Abbreviated New Drug Application Approval
040061 Abbreviated New Drug Application Approval
040110 Abbreviated New Drug Application Approval
040180 Abbreviated New Drug Application Approval
040528 Abbreviated New Drug Application Approval
061214 Abbreviated New Drug Application Approval
062173 Abbreviated New Drug Application Approval
062832 Abbreviated New Drug Application Approval
065178 Abbreviated New Drug Application Approval
065410 Abbreviated New Drug Application Approval
065413 Abbreviated New Drug Application Approval
070086 Abbreviated New Drug Application Approval
070192 Abbreviated New Drug Application Approval
070193 Abbreviated New Drug Application Approval
070194 Abbreviated New Drug Application Approval
070356 Abbreviated New Drug Application Approval
070357 Abbreviated New Drug Application Approval
070358 Abbreviated New Drug Application Approval
070433 Abbreviated New Drug Application Approval
070434 Abbreviated New Drug Application Approval
070516 Abbreviated New Drug Application Approval
070517 Abbreviated New Drug Application Approval
070518 Abbreviated New Drug Application Approval
070519 Abbreviated New Drug Application Approval
070520 Abbreviated New Drug Application Approval
070521 Abbreviated New Drug Application Approval
070690 Abbreviated New Drug Application Approval
070928 Abbreviated New Drug Application Approval
070979 Abbreviated New Drug Application Approval
071010 Abbreviated New Drug Application Approval
071011 Abbreviated New Drug Application Approval
071388 Abbreviated New Drug Application Approval
071415 Abbreviated New Drug Application Approval
072038 Abbreviated New Drug Application Approval
072323 Abbreviated New Drug Application Approval
072324 Abbreviated New Drug Application Approval
072621 Abbreviated New Drug Application Approval
072622 Abbreviated New Drug Application Approval
072733 Abbreviated New Drug Application Approval
072734 Abbreviated New Drug Application Approval
072735 Abbreviated New Drug Application Approval
072736 Abbreviated New Drug Application Approval
072755 Abbreviated New Drug Application Approval
072768 Abbreviated New Drug Application Approval
072769 Abbreviated New Drug Application Approval
072995 Abbreviated New Drug Application Approval
073079 Abbreviated New Drug Application Approval
073080 Abbreviated New Drug Application Approval
073562 Abbreviated New Drug Application Approval
073563 Abbreviated New Drug Application Approval
073590 Abbreviated New Drug Application Approval
073591 Abbreviated New Drug Application Approval
074081 Abbreviated New Drug Application Approval
074190 Abbreviated New Drug Application Approval
074199 Abbreviated New Drug Application Approval
074211 Abbreviated New Drug Application Approval
074224 Abbreviated New Drug Application Approval
074257 Abbreviated New Drug Application Approval
074312 Abbreviated New Drug Application Approval
074314 Abbreviated New Drug Application Approval
074391 Abbreviated New Drug Application Approval
074458 Abbreviated New Drug Application Approval
074476 Abbreviated New Drug Application Approval
074570 Abbreviated New Drug Application Approval
074597 Abbreviated New Drug Application Approval
074648 Abbreviated New Drug Application Approval
074653 Abbreviated New Drug Application Approval
075129 Abbreviated New Drug Application Approval
075175 Abbreviated New Drug Application Approval
075824 Abbreviated New Drug Application Approval
075867 Abbreviated New Drug Application Approval
075873 Abbreviated New Drug Application Approval
075997 Abbreviated New Drug Application Approval
076027 Abbreviated New Drug Application Approval
076196 Abbreviated New Drug Application Approval
076213 Abbreviated New Drug Application Approval
076242 Abbreviated New Drug Application Approval
076246 Abbreviated New Drug Application Approval
076270 Abbreviated New Drug Application Approval
076278 Abbreviated New Drug Application Approval
076306 Abbreviated New Drug Application Approval
076387 Abbreviated New Drug Application Approval
076482 Abbreviated New Drug Application Approval
076489 Abbreviated New Drug Application Approval
076504 Abbreviated New Drug Application Approval
076523 Abbreviated New Drug Application Approval
076598 Abbreviated New Drug Application Approval
076664 Abbreviated New Drug Application Approval
076691 Abbreviated New Drug Application Approval
076832 Abbreviated New Drug Application Approval
076844 Abbreviated New Drug Application Approval
076881 Abbreviated New Drug Application Approval
076904 Abbreviated New Drug Application Approval
076917 Abbreviated New Drug Application Approval
076934 Abbreviated New Drug Application Approval
076943 Abbreviated New Drug Application Approval
076960 Abbreviated New Drug Application Approval
076963 Abbreviated New Drug Application Approval
077024 Abbreviated New Drug Application Approval
077041 Abbreviated New Drug Application Approval
077043 Abbreviated New Drug Application Approval
077214 Abbreviated New Drug Application Approval
077223 Abbreviated New Drug Application Approval
077237 Abbreviated New Drug Application Approval
077249 Abbreviated New Drug Application Approval
077262 Abbreviated New Drug Application Approval
077392 Abbreviated New Drug Application Approval
077431 Abbreviated New Drug Application Approval
077459 Abbreviated New Drug Application Approval
077608 Abbreviated New Drug Application Approval
077648 Abbreviated New Drug Application Approval
077693 Abbreviated New Drug Application Approval
077728 Abbreviated New Drug Application Approval
077732 Abbreviated New Drug Application Approval
077795 Abbreviated New Drug Application Approval
077806 Abbreviated New Drug Application Approval
077842 Abbreviated New Drug Application Approval
077852 Abbreviated New Drug Application Approval
077900 Abbreviated New Drug Application Approval
077925 Abbreviated New Drug Application Approval
077993 Abbreviated New Drug Application Tentative Approval
078004 Abbreviated New Drug Application Approval
078026 Abbreviated New Drug Application Approval
078042 Abbreviated New Drug Application Approval
078185 Abbreviated New Drug Application Approval
078241 Abbreviated New Drug Application Approval
078285 Abbreviated New Drug Application Approval
078470 Abbreviated New Drug Application Approval
078485 Abbreviated New Drug Application Approval
078582 Abbreviated New Drug Application Approval
078633 Abbreviated New Drug Application Approval
078656 Abbreviated New Drug Application Approval
078662 Abbreviated New Drug Application Approval
078695 Abbreviated New Drug Application Tentative Approval
078913 Abbreviated New Drug Application Approval
080082 Abbreviated New Drug Application Approval
080327 Abbreviated New Drug Application Approval
080352 Abbreviated New Drug Application Approval
080626 Abbreviated New Drug Application Approval
080635 Abbreviated New Drug Application Approval
080643 Abbreviated New Drug Application Approval
080927 Abbreviated New Drug Application Approval
083089 Abbreviated New Drug Application Approval
083799 Abbreviated New Drug Application Approval
084122 Abbreviated New Drug Application Approval
084283 Abbreviated New Drug Application Approval
084332 Abbreviated New Drug Application Approval
084536 Abbreviated New Drug Application Approval
084603 Abbreviated New Drug Application Approval
084610 Abbreviated New Drug Application Approval
084611 Abbreviated New Drug Application Approval
084612 Abbreviated New Drug Application Approval
084613 Abbreviated New Drug Application Approval
084614 Abbreviated New Drug Application Approval
084656 Abbreviated New Drug Application Approval
084659 Abbreviated New Drug Application Approval
084667 Abbreviated New Drug Application Approval
084700 Abbreviated New Drug Application Approval
084705 Abbreviated New Drug Application Approval
084706 Abbreviated New Drug Application Approval
084707 Abbreviated New Drug Application Approval
084708 Abbreviated New Drug Application Approval
084709 Abbreviated New Drug Application Approval
084739 Abbreviated New Drug Application Approval
085004 Abbreviated New Drug Application Approval
085005 Abbreviated New Drug Application Approval
085944 Abbreviated New Drug Application Approval
085945 Abbreviated New Drug Application Approval
086002 Abbreviated New Drug Application Approval
086003 Abbreviated New Drug Application Approval
086004 Abbreviated New Drug Application Approval
086057 Abbreviated New Drug Application Approval
086090 Abbreviated New Drug Application Approval
086143 Abbreviated New Drug Application Approval
086144 Abbreviated New Drug Application Approval
086145 Abbreviated New Drug Application Approval
086146 Abbreviated New Drug Application Approval
086147 Abbreviated New Drug Application Approval
086148 Abbreviated New Drug Application Approval
086366 Abbreviated New Drug Application Approval
086899 Abbreviated New Drug Application Approval
087003 Abbreviated New Drug Application Approval
087025 Abbreviated New Drug Application Approval
087324 Abbreviated New Drug Application Approval
087342 Abbreviated New Drug Application Approval
087393 Abbreviated New Drug Application Approval
087396 Abbreviated New Drug Application Approval
087449 Abbreviated New Drug Application Approval
087500 Abbreviated New Drug Application Approval
087501 Abbreviated New Drug Application Approval
087708 Abbreviated New Drug Application Approval
087742 Abbreviated New Drug Application Approval
087743 Abbreviated New Drug Application Approval
087800 Abbreviated New Drug Application Approval
087801 Abbreviated New Drug Application Approval
087833 Abbreviated New Drug Application Approval
087916 Abbreviated New Drug Application Approval
087997 Abbreviated New Drug Application Approval
088108 Abbreviated New Drug Application Approval
088109 Abbreviated New Drug Application Approval
088126 Abbreviated New Drug Application Approval
088226 Abbreviated New Drug Application Approval
088248 Abbreviated New Drug Application Approval
088252 Abbreviated New Drug Application Approval
088275 Abbreviated New Drug Application Approval
088306 Abbreviated New Drug Application Approval
088316 Abbreviated New Drug Application Approval
088453 Abbreviated New Drug Application Approval
088539 Abbreviated New Drug Application Approval
088587 Abbreviated New Drug Application Approval
088588 Abbreviated New Drug Application Approval
088646 Abbreviated New Drug Application Approval
088647 Abbreviated New Drug Application Approval
088663 Abbreviated New Drug Application Approval
088664 Abbreviated New Drug Application Approval
088665 Abbreviated New Drug Application Approval
088703 Abbreviated New Drug Application Approval
088744 Abbreviated New Drug Application Approval
088802 Abbreviated New Drug Application Approval
088803 Abbreviated New Drug Application Approval
088810 Abbreviated New Drug Application Approval
088941 Abbreviated New Drug Application Approval
088942 Abbreviated New Drug Application Approval
088989 Abbreviated New Drug Application Approval
088990 Abbreviated New Drug Application Approval
089048 Abbreviated New Drug Application Approval
089049 Abbreviated New Drug Application Approval
089351 Abbreviated New Drug Application Approval
089511 Abbreviated New Drug Application Approval
089512 Abbreviated New Drug Application Approval
089513 Abbreviated New Drug Application Approval
089775 Abbreviated New Drug Application Approval
089897 Abbreviated New Drug Application Approval
090072 Abbreviated New Drug Application Approval
090120 Abbreviated New Drug Application Approval
090128 Abbreviated New Drug Application Approval
090201 Abbreviated New Drug Application Approval
090351 Abbreviated New Drug Application Approval
090381 Abbreviated New Drug Application Approval
090520 Abbreviated New Drug Application Approval
090655 Abbreviated New Drug Application Approval
090749 Abbreviated New Drug Application Approval
090838 Abbreviated New Drug Application Approval
090964 Abbreviated New Drug Application Approval
091099 Abbreviated New Drug Application Approval
091128 Abbreviated New Drug Application Approval
091153 Abbreviated New Drug Application Approval
091433 Abbreviated New Drug Application Approval
091444 Abbreviated New Drug Application Approval
091591 Abbreviated New Drug Application Approval
200068 Abbreviated New Drug Application Approval
200483 Abbreviated New Drug Application Approval
200652 Abbreviated New Drug Application Approval
200822 Abbreviated New Drug Application Approval
201050 Abbreviated New Drug Application Approval
201172 Abbreviated New Drug Application Approval
201193 Abbreviated New Drug Application Approval
202204 Abbreviated New Drug Application Approval
202245 New Drug Application Approval New manufacturer (S) Standard review drug
202573 Abbreviated New Drug Application Approval
202652 Abbreviated New Drug Application Approval
202827 Abbreviated New Drug Application Tentative Approval
203208 Abbreviated New Drug Application Approval
203326 Abbreviated New Drug Application Approval
203846 Abbreviated New Drug Application Approval
203856 New Drug Application Approval New manufacturer (S) Standard review drug
204037 Abbreviated New Drug Application Approval
204082 Abbreviated New Drug Application Approval
204083 Abbreviated New Drug Application Approval
204988 Abbreviated New Drug Application Approval
205057 Abbreviated New Drug Application Tentative Approval
206646 Abbreviated New Drug Application Tentative Approval
207957 Abbreviated New Drug Application Approval

Back to Companies who have applied for FDA Drug Approval