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FDA Drug Approval Applications Sponsored by NOVARTIS

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
003240 New Drug Application Approval
005151 New Drug Application Approval
005914
PBZ
New Drug Application Approval New molecular entity (NME) (S) Standard review drug
006008 New Drug Application Approval
006203 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
006403 New Drug Application Approval
006620 New Drug Application Approval
008278 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
008303 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
008319 New Drug Application Approval New molecular entity (NME); New combination (S) Standard review drug
008492 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
008822 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
009000 New Drug Application Approval New combination (P) Priority review drug
009087 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
009115 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug
009215 New Drug Application Approval New manufacturer (S) Standard review drug
009282 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
009296 New Drug Application Approval New combination (S) Standard review drug
009434 New Drug Application Approval New formulation (S) Standard review drug
009436 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
010187 New Drug Application Approval New formulation (S) Standard review drug
010533 New Drug Application Approval New manufacturer (S) Standard review drug
011556 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011793 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011808 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
011838 New Drug Application Approval New formulation (S) Standard review drug
011878 New Drug Application Approval New combination (S) Standard review drug
012026 New Drug Application Approval New combination (S) Standard review drug
012193 New Drug Application Approval New combination (S) Standard review drug
012329 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
012516 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
012542 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
012753 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
012754 New Drug Application Approval New formulation (S) Standard review drug
013247 New Drug Application Approval New formulation (S) Standard review drug
013420 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
013553 New Drug Application Approval New combination (S) Standard review drug
016211 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
016267 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016379 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
016608 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016755 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
016774 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
016775 New Drug Application Approval New formulation (S) Standard review drug
016997 New Drug Application Approval New formulation (S) Standard review drug
017247 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017476 New Drug Application Approval New manufacturer (S) Standard review drug
017543 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017661 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017851 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017869 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017923 New Drug Application Approval New formulation (S) Standard review drug
017993 New Drug Application Approval New formulation (S) Standard review drug
018029 New Drug Application Approval New manufacturer (S) Standard review drug
018115 New Drug Application Approval New manufacturer (S) Standard review drug
018121 New Drug Application Approval New manufacturer (S) Standard review drug
018166 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018202 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
018245 New Drug Application Approval New manufacturer (S) Standard review drug
018281 New Drug Application Approval New formulation (S) Standard review drug
018285 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
018418 New Drug Application Approval New formulation (S) Standard review drug
018470 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
018675 New Drug Application Approval New formulation (S) Standard review drug
018704 New Drug Application Approval New formulation (P) Priority review drug
018706 New Drug Application Approval New formulation (S) Standard review drug
018746 New Drug Application Approval New indication (S) Standard review drug
018762 New Drug Application Approval New formulation (S) Standard review drug
018872 New Drug Application Approval New combination (S) Standard review drug
018885 New Drug Application Approval New combination (P) Priority review drug
018927 New Drug Application Approval New formulation (S) Standard review drug
018988 New Drug Application Approval New combination (S) Standard review drug
019081 New Drug Application Approval New formulation (S) Standard review drug
019201 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
019381 New Drug Application Approval New manufacturer (S) Standard review drug
019451 New Drug Application Approval New combination (S) Standard review drug
019500 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
019667 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019786 New Drug Application Approval New ester, new salt, or other noncovalent derivative; New formulation (S) Standard review drug
019972 New Drug Application Approval New formulation (S) Standard review drug
020036 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020037 New Drug Application Approval New formulation (P) Priority review drug
020142 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
020144 New Drug Application Approval
020192 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020219 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020234 New Drug Application Approval New formulation (S) Standard review drug
020254 New Drug Application Approval New formulation (S) Standard review drug
020261 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020323 New Drug Application Approval New formulation (S) Standard review drug
020363 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020364 New Drug Application Approval New combination (S) Standard review drug
020538 New Drug Application Approval New manufacturer (S) Standard review drug
020539 New Drug Application Approval New formulation (S) Standard review drug
020665 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020676 New Drug Application Approval OTC (over-the-counter) switch (S) Standard review drug
020818 New Drug Application Approval New combination (S) Standard review drug
020823 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020831 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020925 New Drug Application Approval OTC (over-the-counter) switch
020927 New Drug Application Approval New indication (S) Standard review drug
020961 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020980 New Drug Application Approval OTC (over-the-counter) switch (S) Standard review drug
021008 New Drug Application Approval New formulation (P) Priority review drug (V) Orphan drug
021014 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021025 New Drug Application Approval New formulation (S) Standard review drug
021082 New Drug Application Approval New combination (S) Standard review drug
021124 New Drug Application Approval OTC (over-the-counter) switch (S) Standard review drug
021167 New Drug Application Approval New formulation (S) Standard review drug
021192 New Drug Application Approval New formulation (S) Standard review drug
021204 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021223 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
021278 New Drug Application Approval New formulation (S) Standard review drug
021279 New Drug Application Approval New indication (S) Standard review drug
021283 New Drug Application Approval New formulation (S) Standard review drug
021284 New Drug Application Approval New formulation (S) Standard review drug
021285 New Drug Application Approval New formulation (S) Standard review drug
021335 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
021386 New Drug Application Approval New indication (P) Priority review drug
021560 New Drug Application Approval New manufacturer (S) Standard review drug
021588 New Drug Application Approval New formulation
021592 New Drug Application Approval New formulation (S) Standard review drug
021802 New Drug Application Approval New formulation (S) Standard review drug
021817 New Drug Application Approval New formulation (P) Priority review drug
021882 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
021958 New Drug Application Approval OTC (over-the-counter) switch (S) Standard review drug
021985 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
021990 New Drug Application Approval New combination (S) Standard review drug
022011 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022068 New Drug Application Approval New molecular entity (NME) (S) Standard review drug (V) Orphan drug
022071 New Drug Application Approval New formulation (S) Standard review drug
022083 New Drug Application Approval New formulation (S) Standard review drug
022107 New Drug Application Approval New combination (S) Standard review drug
022154 New Drug Application Approval New formulation (S) Standard review drug
022217 New Drug Application Approval New combination (S) Standard review drug
022268 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
022314 New Drug Application Approval New combination (S) Standard review drug
022334 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
022383 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022470 New Drug Application Approval New formulation (S) Standard review drug
022527 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
022545 New Drug Application Approval New combination (S) Standard review drug
050573 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
050574 New Drug Application Approval New formulation (P) Priority review drug
050625 New Drug Application Approval New formulation (P) Priority review drug
050715 New Drug Application Approval New formulation (S) Standard review drug
050716 New Drug Application Approval New formulation (S) Standard review drug
050791 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
062480 Abbreviated New Drug Application Approval
062501 Abbreviated New Drug Application Approval
062544 Abbreviated New Drug Application Approval
062566 Abbreviated New Drug Application Approval
070185 Abbreviated New Drug Application Approval
072687 Abbreviated New Drug Application Approval
073677 Abbreviated New Drug Application Approval
074857 Abbreviated New Drug Application Approval
077656 Abbreviated New Drug Application Approval
077658 Abbreviated New Drug Application Approval
080025 Abbreviated New Drug Application Approval
080235 Abbreviated New Drug Application Approval
080751 Abbreviated New Drug Application Approval
080935
INH
Abbreviated New Drug Application Approval
083149
PBZ
Abbreviated New Drug Application Approval
084735 Abbreviated New Drug Application Approval
084810 Abbreviated New Drug Application Approval
084811 Abbreviated New Drug Application Approval
085148 Abbreviated New Drug Application Approval
086765 Abbreviated New Drug Application Approval
088791 Abbreviated New Drug Application Approval
089047 Abbreviated New Drug Application Approval
103764 Biologic License Application Approval
200045 New Drug Application Approval New combination (S) Standard review drug
200677 New Drug Application Approval New molecular entity (NME) (S) Standard review drug (V) Orphan drug
201688 New Drug Application Approval New formulation (S) Standard review drug

Back to Companies who have applied for FDA Drug Approval


 

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