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FDA Drug Approval Applications Sponsored by FRESENIUS KABI USA

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
006488 New Drug Application Approval
009435 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
009470 New Drug Application Approval New formulation (P) Priority review drug
010417 New Drug Application Approval New formulation (P) Priority review drug
016297 New Drug Application Approval New formulation (P) Priority review drug
016801 New Drug Application Approval New manufacturer (S) Standard review drug
017029 New Drug Application Approval New manufacturer (S) Standard review drug
017067 New Drug Application Approval New manufacturer (S) Standard review drug
017584 New Drug Application Approval New manufacturer (S) Standard review drug
017651 New Drug Application Approval New manufacturer (S) Standard review drug
018248 New Drug Application Approval New manufacturer (S) Standard review drug
018304 New Drug Application Approval
018902 New Drug Application Approval New manufacturer (S) Standard review drug
019264 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug* (V) Orphan drug
019316 New Drug Application Approval New manufacturer (S) Standard review drug
019627 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019887 New Drug Application Approval New formulation (P*) Priority review drug* (V) Orphan drug
020533 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022536 New Drug Application Approval New manufacturer (S) Standard review drug
040258 Abbreviated New Drug Application Approval
040263 Abbreviated New Drug Application Approval
040265 Abbreviated New Drug Application Approval
040266 Abbreviated New Drug Application Approval
040278 Abbreviated New Drug Application Approval
040279 Abbreviated New Drug Application Approval
040286 Abbreviated New Drug Application Approval
040291 Abbreviated New Drug Application Approval
040379 Abbreviated New Drug Application Approval
040388 Abbreviated New Drug Application Approval
040491 Abbreviated New Drug Application Approval
040519 Abbreviated New Drug Application Approval
040572 Abbreviated New Drug Application Approval
040583 Abbreviated New Drug Application Approval
040612 Abbreviated New Drug Application Approval
050789 New Drug Application Approval New manufacturer (S) Standard review drug
062356 Abbreviated New Drug Application Approval
062365 Abbreviated New Drug Application Approval
062366 Abbreviated New Drug Application Approval
062475 Abbreviated New Drug Application Approval
062663 Abbreviated New Drug Application Approval
063277 Abbreviated New Drug Application Approval
064169 Abbreviated New Drug Application Approval
064170 Abbreviated New Drug Application Approval
064200 Abbreviated New Drug Application Approval
064201 Abbreviated New Drug Application Approval
065000 Abbreviated New Drug Application Approval
065001 Abbreviated New Drug Application Approval
065002 Abbreviated New Drug Application Approval
065011 Abbreviated New Drug Application Approval
065012 Abbreviated New Drug Application Approval
065034 Abbreviated New Drug Application Approval
065111 Abbreviated New Drug Application Approval
065116 Abbreviated New Drug Application Approval
065120 Abbreviated New Drug Application Approval
065122 Abbreviated New Drug Application Approval
065179 Abbreviated New Drug Application Approval
065185 Abbreviated New Drug Application Approval
065245 Abbreviated New Drug Application Approval
065252 Abbreviated New Drug Application Approval
065346 Abbreviated New Drug Application Approval
065347 Abbreviated New Drug Application Approval
065364 Abbreviated New Drug Application Approval
065372 Abbreviated New Drug Application Approval
065374 Abbreviated New Drug Application Approval
065375 Abbreviated New Drug Application Approval
065408 Abbreviated New Drug Application Approval
065439 Abbreviated New Drug Application Approval
065440 Abbreviated New Drug Application Approval
065453 Abbreviated New Drug Application Approval
070552 Abbreviated New Drug Application Approval
070553 Abbreviated New Drug Application Approval
070554 Abbreviated New Drug Application Approval
070966 Abbreviated New Drug Application Approval
070967 Abbreviated New Drug Application Approval
070968 Abbreviated New Drug Application Approval
071050 Abbreviated New Drug Application Approval
071051 Abbreviated New Drug Application Approval
071052 Abbreviated New Drug Application Approval
071053 Abbreviated New Drug Application Approval
071202 Abbreviated New Drug Application Approval
071413 Abbreviated New Drug Application Approval
074679 Abbreviated New Drug Application Approval
074735 Abbreviated New Drug Application Approval
074893 Abbreviated New Drug Application Approval
074930 Abbreviated New Drug Application Approval
074956 Abbreviated New Drug Application Approval
074983 Abbreviated New Drug Application Approval
075015 Abbreviated New Drug Application Approval
075154 Abbreviated New Drug Application Approval
075371 Abbreviated New Drug Application Approval
075689 Abbreviated New Drug Application Approval
075698 Abbreviated New Drug Application Approval
075709 Abbreviated New Drug Application Approval
075761 Abbreviated New Drug Application Approval
075773 Abbreviated New Drug Application Approval
075784 Abbreviated New Drug Application Approval
075811 Abbreviated New Drug Application Approval
075813 Abbreviated New Drug Application Approval
075826 Abbreviated New Drug Application Approval
075836 Abbreviated New Drug Application Approval
075837 Abbreviated New Drug Application Approval
075906 Abbreviated New Drug Application Approval
075936 Abbreviated New Drug Application Approval
076078 Abbreviated New Drug Application Approval
076145 Abbreviated New Drug Application Approval
076207 Abbreviated New Drug Application Approval
076235 Abbreviated New Drug Application Approval
076296 Abbreviated New Drug Application Approval
076401 Abbreviated New Drug Application Approval
076484 Abbreviated New Drug Application Approval
076512 Abbreviated New Drug Application Approval
076539 Abbreviated New Drug Application Approval
076571 Abbreviated New Drug Application Approval
076573 Abbreviated New Drug Application Approval
076849 Abbreviated New Drug Application Approval
076887 Abbreviated New Drug Application Approval
076955 Abbreviated New Drug Application Approval
076972 Abbreviated New Drug Application Approval
076974 Abbreviated New Drug Application Approval
077133 Abbreviated New Drug Application Approval
077247 Abbreviated New Drug Application Approval
077266 Abbreviated New Drug Application Approval
077450 Abbreviated New Drug Application Approval
077457 Abbreviated New Drug Application Approval
077496 Abbreviated New Drug Application Approval
077776 Abbreviated New Drug Application Approval
077997 Abbreviated New Drug Application Approval
078002 Abbreviated New Drug Application Approval
078052 Abbreviated New Drug Application Approval
078090 Abbreviated New Drug Application Approval
078096 Abbreviated New Drug Application Approval
078393 Abbreviated New Drug Application Approval
078522 Abbreviated New Drug Application Approval
078544 Abbreviated New Drug Application Approval
078651 Abbreviated New Drug Application Approval
078718 Abbreviated New Drug Application Approval
078819 Abbreviated New Drug Application Approval
079240 Abbreviated New Drug Application Approval
079242 Abbreviated New Drug Application Approval
080225 Abbreviated New Drug Application Approval
080404 Abbreviated New Drug Application Approval
080556 Abbreviated New Drug Application Approval
080557 Abbreviated New Drug Application Approval
080618 Abbreviated New Drug Application Approval
080677 Abbreviated New Drug Application Approval
080722 Abbreviated New Drug Application Approval
084916 Abbreviated New Drug Application Approval
087329 Abbreviated New Drug Application Approval
087817 Abbreviated New Drug Application Approval
088184 Abbreviated New Drug Application Approval
088185 Abbreviated New Drug Application Approval
088400 Abbreviated New Drug Application Approval
088469 Abbreviated New Drug Application Approval
088586 Abbreviated New Drug Application Approval
088901 Abbreviated New Drug Application Approval
088908 Abbreviated New Drug Application Approval
088911 Abbreviated New Drug Application Approval
088912 Abbreviated New Drug Application Approval
089003 Abbreviated New Drug Application Approval
089202 Abbreviated New Drug Application Approval
089406 Abbreviated New Drug Application Approval
089407 Abbreviated New Drug Application Approval
089408 Abbreviated New Drug Application Approval
089409 Abbreviated New Drug Application Approval
089410 Abbreviated New Drug Application Approval
089454 Abbreviated New Drug Application Approval
089515 Abbreviated New Drug Application Approval
089556 Abbreviated New Drug Application Approval
090181 Abbreviated New Drug Application Approval
090189 Abbreviated New Drug Application Approval
090233 Abbreviated New Drug Application Approval
090242 Abbreviated New Drug Application Approval
090658 Abbreviated New Drug Application Approval
090813 Abbreviated New Drug Application Approval
090876 Abbreviated New Drug Application Approval
090896 Abbreviated New Drug Application Approval
091045 Abbreviated New Drug Application Approval
091089 Abbreviated New Drug Application Approval
091181 Abbreviated New Drug Application Approval
091392 Abbreviated New Drug Application Approval
091516 Abbreviated New Drug Application Approval
091526 Abbreviated New Drug Application Approval
091596 Abbreviated New Drug Application Approval
200644 Abbreviated New Drug Application Approval
200656 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
200673 Abbreviated New Drug Application Approval
200674 Abbreviated New Drug Application Approval
201072 Abbreviated New Drug Application Approval
201811 New Drug Application Approval New manufacturer (S) Standard review drug
201849 New Drug Application Approval New manufacturer (S) Standard review drug
202231 New Drug Application Approval Drug already marketed, but without an approved NDA (S) Standard review drug
202253 Abbreviated New Drug Application Approval
203129 Abbreviated New Drug Application Approval
203182 Abbreviated New Drug Application Approval
203183 Abbreviated New Drug Application Approval
203242 Abbreviated New Drug Application Approval
203460 Abbreviated New Drug Application Approval
203629 New Drug Application Approval New formulation (S) Standard review drug
204223 New Drug Application Approval New manufacturer (S) Standard review drug
204764 Abbreviated New Drug Application Approval
204767 New Drug Application Approval New manufacturer (S) Standard review drug
205004 New Drug Application Tentative Approval New manufacturer
205572 New Drug Application Approval New manufacturer (S) Standard review drug
205604 Abbreviated New Drug Application Approval
205605 Abbreviated New Drug Application Approval
205645 New Drug Application Tentative Approval New manufacturer
206110 New Drug Application Tentative Approval New manufacturer
206197 Abbreviated New Drug Application Approval
206485 Abbreviated New Drug Application Approval
206486 Abbreviated New Drug Application Approval
206552 Abbreviated New Drug Application Approval
207449 Abbreviated New Drug Application Approval
207648 New Drug Application Approval New combination (S) Standard review drug
208109 New Drug Application Tentative Approval New manufacturer

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