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FDA applications

Approved and filed applications connected to their products and owning companies.

29,787 results

ApplicationApplicantApplication number
NDA 211358VERTEX PHARMACEUTICALS INCNDA211358
NDA 211363INTERNATIONAL MEDICATION SYSTEMS LTDNDA211363
NDA 211367EXELTIS USA INCNDA211367
NDA 211371SAGE THERAPEUTICS LLC A WHOLLY OWNED SUB OF SUPERNUS PHARMACEUTICALS INCNDA211371
NDA 211379DEXCEL PHARMA TECHNOLOGIES LTDNDA211379
NDA 211413HQ SPECIALTY PHARMA CORPNDA211413
NDA 211415ESTEVE PHARMACEUTICALS SANDA211415
NDA 211448CMG PHARMACEUTICAL CO LTDNDA211448
NDA 211488ACCORD BIOPHARMA INCNDA211488
NDA 211527GALDERMA LABORATORIES LPNDA211527
NDA 211530HOSPIRA INCNDA211530
NDA 211566ZYDUS LIFESCIENCES GLOBAL FZENDA211566
NDA 211580NOVADAQ TECHNOLOGIES ULCNDA211580
NDA 211616ESPERION THERAPEUTICS INCNDA211616
NDA 211617ESPERION THERAPEUTICS INCNDA211617
NDA 211635NEURELIS INCNDA211635
NDA 211651PFIZER INCNDA211651
NDA 211672HONG KONG KING FRIEND INDUSTRIAL CO LTDNDA211672
NDA 211673HONG KONG KING FRIEND INDUSTRIAL CO LTDNDA211673
NDA 211675ABBVIE INCNDA211675
NDA 211710BAYER HEALTHCARE PHARMACEUTICALS INCNDA211710
NDA 211723EPIZYME INCNDA211723
NDA 211728UROGEN PHARMA LTDNDA211728
NDA 211733HALEON US HOLDINGS LLCNDA211733
NDA 211737CRISTAL ASU LLCNDA211737
NDA 211739CRISTAL ASU LLCNDA211739
NDA 211746GLENMARK SPECIALTY SANDA211746
NDA 211759CARWIN PHARMACEUTICAL ASSOCIATES LLCNDA211759
NDA 211765ABBVIE INCNDA211765
NDA 211781A-OX WELDING SUPPLY CO, INC.NDA211781
NDA 211801ARDELYX INCNDA211801
NDA 211810DAIICHI SANKYO INCNDA211810
NDA 211843MISSION PHARMACAL CONDA211843
NDA 211844INFORLIFE SANDA211844
NDA 211855BIOGEN INCNDA211855
NDA 211868EMCURE PHARMS LTDNDA211868
NDA 211875AMERICAN REGENT INCNDA211875
NDA 211882BAUSCH HEALTH US LLCNDA211882
NDA 211911ABBVIE INCNDA211911
NDA 211912CELLTRION INCNDA211912
NDA 211913SUN PHARMACEUTICAL INDUSTRIES LTDNDA211913
NDA 211929SUN PHARMACEUTICAL INDUSTRIES INCNDA211929
NDA 211939ALVOGEN INCNDA211939
NDA 211950BAUSCH AND LOMB INCNDA211950
NDA 211962HIKMA PHARMSNDA211962
NDA 211964SUPERNUS PHARMACEUTICALS INCNDA211964
NDA 211970SAREPTA THERAPEUTICS INCNDA211970
NDA 211988HERON THERAPEUTICS INCNDA211988
NDA 211994VIIV HEALTHCARE CONDA211994
NDA 211996FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INCNDA211996