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FDA Drug Approval Applications Sponsored by GLAXOSMITHKLINE

Application NumberDrugs/ProductsApplication TypeMost Recent Label Available FlagCurrent Patent FlagAction TypeChemical TypeTher PotentialOrphan Code
006772 New Drug Application Approval
006931 New Drug Application Approval
009102 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug
009149 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
009309 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
009495 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
010571 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
010742 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
010744 New Drug Application Approval New formulation (S) Standard review drug
011000 New Drug Application Approval New formulation (S) Standard review drug
011110 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011120 New Drug Application Approval New formulation (S) Standard review drug
011127 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
011188 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
011276 New Drug Application Approval New formulation (S) Standard review drug
011496 New Drug Application Approval New formulation (S) Standard review drug
011552 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
011945 New Drug Application Approval New formulation (S) Standard review drug
012575 New Drug Application Approval New combination (S) Standard review drug
013934 New Drug Application Approval New manufacturer (S) Standard review drug
015868 New Drug Application Approval New formulation (S) Standard review drug
016033 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
017352 New Drug Application Approval New formulation (S) Standard review drug
017369 New Drug Application Approval New manufacturer (S) Standard review drug
017920 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
017924 New Drug Application Approval New ester, new salt, or other noncovalent derivative (P) Priority review drug
017939 New Drug Application Approval New formulation (P) Priority review drug
017941 New Drug Application Approval New manufacturer (S) Standard review drug
018153 New Drug Application Approval New manufacturer (S) Standard review drug
018342 New Drug Application Approval New formulation (S) Standard review drug (V) Orphan drug
018473 New Drug Application Approval New manufacturer (P) Priority review drug
018584 New Drug Application Approval New manufacturer (S) Standard review drug
018603 New Drug Application Approval New ester, new salt, or other noncovalent derivative; New formulation (P) Priority review drug
018612 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
018644 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
018996 New Drug Application Approval New formulation (S) Standard review drug
019112 New Drug Application Approval New manufacturer (S) Standard review drug
019174 New Drug Application Approval New manufacturer (S) Standard review drug
019269 New Drug Application Approval New manufacturer (S) Standard review drug
019389 New Drug Application Approval New formulation (S) Standard review drug
019434 New Drug Application Approval New formulation (S) Standard review drug
019435
NIX
New Drug Application Approval New molecular entity (NME) (P) Priority review drug
019489 New Drug Application Approval New formulation (S) Standard review drug
019621 New Drug Application Approval New manufacturer (S) Standard review drug
019773 New Drug Application Approval New formulation (S) Standard review drug
020044 New Drug Application Approval New molecular entity (NME); New combination (P) Priority review drug (V) Orphan drug
020066 New Drug Application Approval New manufacturer (S) Standard review drug
020080 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020095 New Drug Application Approval New formulation (S) Standard review drug
020121 New Drug Application Approval New formulation (S) Standard review drug
020132 New Drug Application Approval New formulation (S) Standard review drug
020236 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
020250 New Drug Application Approval New molecular entity (NME) (P) Priority review drug (V) Orphan drug
020358 New Drug Application Approval New formulation (S) Standard review drug
020403 New Drug Application Approval New formulation (S) Standard review drug
020487 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
020548 New Drug Application Approval New formulation (S) Standard review drug
020549 New Drug Application Approval New formulation (S) Standard review drug
020550 New Drug Application Approval New indication (P) Priority review drug
020559 New Drug Application Approval New ester, new salt, or other noncovalent derivative; New combination (S) Standard review drug
020626 New Drug Application Approval New formulation (S) Standard review drug
020692 New Drug Application Approval New formulation (S) Standard review drug
020711 New Drug Application Approval New formulation (S) Standard review drug
020941 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
020951 New Drug Application Approval New formulation (S) Standard review drug
020983 New Drug Application Approval New formulation (S) Standard review drug
021003 New Drug Application Approval New formulation (P) Priority review drug
021004 New Drug Application Approval New formulation (P) Priority review drug
021007 New Drug Application Approval New molecular entity (NME) (P*) Priority review drug*
021019 New Drug Application Approval New formulation (S) Standard review drug
021036 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
021039 New Drug Application Approval New formulation (P*) Priority review drug*
021078 New Drug Application Approval New combination (P) Priority review drug
021319 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022051 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
022345 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
022460 New Drug Application Approval New combination (S) Standard review drug
050167 New Drug Application Approval
050176 New Drug Application Approval
050298 New Drug Application Approval
050459 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
050460 New Drug Application Approval New formulation (P) Priority review drug
050461 New Drug Application Approval
050497 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
050579 New Drug Application Approval New molecular entity (NME) (P) Priority review drug
050590 New Drug Application Approval New combination (P) Priority review drug
050591 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
050605 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
050646 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
050658 New Drug Application Approval New formulation (S) Standard review drug
050672 New Drug Application Approval New formulation (S) Standard review drug
050703 New Drug Application Approval New ester, new salt, or other noncovalent derivative (S) Standard review drug
050746 New Drug Application Approval New formulation (S) Standard review drug
060060 Abbreviated New Drug Application Approval
060254 Abbreviated New Drug Application Approval
060666 Abbreviated New Drug Application Approval
060677 Abbreviated New Drug Application Approval
061334 Abbreviated New Drug Application Approval
061336 Abbreviated New Drug Application Approval
061806 Abbreviated New Drug Application Approval
061859 Abbreviated New Drug Application Approval
061866 Abbreviated New Drug Application Approval
061999 Abbreviated New Drug Application Approval
062036 Abbreviated New Drug Application Approval
062212 Abbreviated New Drug Application Approval
062223 Abbreviated New Drug Application Approval
062233 Abbreviated New Drug Application Approval
062238 Abbreviated New Drug Application Approval
062241 Abbreviated New Drug Application Approval
062270 Abbreviated New Drug Application Approval
062273 Abbreviated New Drug Application Approval
062321 Abbreviated New Drug Application Approval
062435 Abbreviated New Drug Application Approval
062690 Abbreviated New Drug Application Approval
062691 Abbreviated New Drug Application Approval
062727 Abbreviated New Drug Application Approval
062736 Abbreviated New Drug Application Approval
062755 Abbreviated New Drug Application Approval
063295 Abbreviated New Drug Application Approval
063322 Abbreviated New Drug Application Approval
064006 Abbreviated New Drug Application Approval
064008 Abbreviated New Drug Application Approval
064033 Abbreviated New Drug Application Approval
083902 Abbreviated New Drug Application Approval
083951 Abbreviated New Drug Application Approval
084060 Abbreviated New Drug Application Approval
084935 Abbreviated New Drug Application Approval
087439 Abbreviated New Drug Application Approval
089465 Abbreviated New Drug Application Approval
089833 Abbreviated New Drug Application Approval
089834 Abbreviated New Drug Application Approval
203975 New Drug Application Approval New molecular entity (NME) (S) Standard review drug
205625 New Drug Application Approval New manufacturer (S) Standard review drug

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