NDA submission

Related by string. NDA Submission * NDAs . NDAS . nda . Nda : NDA convenor Sharad Yadav . NDA convener George . NDA convener . NDA Convener George . Alliance NDA . NDA convenor George / submissions . Submissions . Submission . SUBMISSION . SUBMISSIONS : Letters submission form . submission triangle choke . submission guillotine choke . spam submissions . Submission deadline * EvaMist NDA submission *

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(Click for frequent words.) 76 New Drug Application 73 BLA submission 72 Biologics License Application BLA 70 Biologics License Application 68 BLA filing 67 MAA submission 67 registrational 67 IND submission 67 NDA resubmission 66 sNDA submission 66 NEBIDO 65 SILENOR TM 65 Marqibo 64 sNDA 64 oral ridaforolimus 63 Phase III clinical 63 pivotal Phase III 63 octreotide implant 63 OFIRMEV 63 Phase Ib 63 Marketing Authorization Application MAA 63 PMA submission 63 PREOS 62 confirmatory Phase III 62 Marketing Authorization Application 62 T Pred 62 APF# 62 confirmatory Phase 3 62 IND enabling 62 Phase IIa trials 62 Phase III clinical trials 62 Phase 2b study 62 Acetavance 62 Phase 2b trial 61 SILENOR 61 Phase 1b trial 61 Premarket Approval PMA 61 Biologic License Application BLA 61 QNEXA 61 Phase IIb trial 61 Orathecin 61 Amoxicillin PULSYS 61 indiplon capsules 61 Complete Response 61 ZEGERID Capsules 61 sBLA 61 phase IIb 61 FDA approvable letter 61 IND Investigational New 61 Phase III pivotal 61 ruxolitinib 61 ONCONASE 60 Icatibant 60 Phase 2b clinical 60 vilazodone 60 teduglutide 60 Omigard 60 Phenoptin 60 Corlux 60 alvimopan 60 Exelbine 60 Phase III trials 60 IIa trial 60 Phase Ib study 60 Biologic License Application 60 Zelrix 60 PDUFA date 60 lorcaserin NDA 60 PREOS R 60 PhosLo 60 Urocidin 60 oxymorphone ER 59 Phase IIb clinical 59 Strativa 59 oral calcitonin 59 Dyloject TM 59 MONOVISC 59 Civacir 59 Intermezzo R 59 rALLy trial 59 Phase IIb trials 59 satraplatin 59 Stavzor 59 Intermezzo ® NDA 59 Fodosine 59 Phase IIIb clinical 59 NUVIGIL 59 liprotamase 59 MBP# [001] 59 palifosfamide 59 initiate Phase IIb 59 ATryn R 59 GALNS 59 Trizytek 59 balsalazide tablet 59 Phase 1b 59 Phase IIa trial 59 Zerenex 59 Phase IIb 59 Neurodex 59 forodesine 59 dirucotide 59 faropenem 59 torezolid phosphate 59 TOCOSOL Paclitaxel 58 phase IIb trial 58 APF# NDA 58 CORLUX 58 FORTIS M trial 58 VEGF Trap 58 ANTEGREN 58 severe hypercholesterolemia 58 phase Ib 58 supplemental Biologics License Application 58 peginesatide 58 Junovan 58 zileuton CR 58 Phase III 58 LibiGel 58 FDA Complete Response 58 Marketing Authorisation Application 58 Qutenza 58 BENLYSTA 58 SUCCEED trial 58 BLOOM DM 58 PDE4 inhibitor 58 CIP TRAMADOL ER 58 celgosivir 58 Marketing Authorisation Application MAA 58 maribavir 58 BEMA TM Fentanyl 58 SPARLON 58 Phase #b/#a 58 Voraxaze 58 SILENOR ™ 58 Phase 2a trial 58 Kuvan 58 Renvela 58 elotuzumab 58 ONSOLIS 58 sNDA filing 58 proprietary transdermal patch 58 Board DSMB 58 Restanza 58 Investigational Device Exemption 58 talactoferrin 57 phase IIb clinical 57 Probuphine 57 Rhucin 57 GLP toxicology studies 57 Phase 2b 57 ponatinib 57 alogliptin 57 Zenvia ™ 57 Alzhemed TM 57 pharmacokinetic studies 57 bicifadine 57 Cellegesic 57 Phase IIb clinical trials 57 phase IIa 57 Oracea 57 FIRAZYR 57 PLK1 SNALP 57 Dacogen injection 57 Velac 57 PIX# trial 57 vernakalant oral 57 viral kinetic 57 FDA Approvable Letter 57 L MTP PE 57 Pennsaid 57 RSD# 57 Bicifadine 57 Phase IIa clinical trials 57 application sNDA 57 Zensana 57 Phase IIB 57 Ereska 57 CIP ISOTRETINOIN 57 BYDUREON 57 apaziquone 57 Nebido 57 Q#IR 57 Phase 2a 57 registrational trial 57 PEG PAL 57 Luveniq 57 TRANSDUR Sufentanil 57 Moxatag 57 CoFactor 57 Exalgo 57 JAK inhibitor 57 pradefovir 57 ENRICH trial 57 ofatumumab 57 Zolpimist 57 valopicitabine 57 AzaSite Plus 57 Bepreve 57 tolevamer 57 Hematide ™ 57 HCV protease inhibitor 57 RIGScan CR 57 AeroLEF TM 57 NGX# 57 INDs 57 NDA Submission 57 deforolimus 57 granulated mesalamine 57 ridaforolimus 57 Application BLA 57 Aryplase 57 mipomersen 57 DR Cysteamine 57 LibiGel ® 56 Phase 2a clinical trials 56 CRMD# 56 pegloticase 56 Plenaxis TM 56 alvespimycin 56 ONCONASE R 56 Zenvia TM 56 Amigal 56 Investigational Device Exemption IDE 56 Phase Ib II 56 Evamist TM 56 Anturol TM 56 Ketotransdel 56 diabetic neuropathic pain 56 Flutiform ™ 56 placebo controlled Phase 56 Bronchitol 56 dalbavancin 56 Somatuline R Autogel R 56 ZEGERID Chewable Tablets 56 fidaxomicin 56 EOquin 56 PS# [001] 56 Preotact 56 INCB# [002] 56 Pennsaid R 56 Frova ® 56 NVA# 56 Investigational 56 brentuximab vedotin 56 Fast Track designation 56 Sular formulation 56 tezampanel 56 Phase IIa 56 resubmission 56 investigational compound 56 Glybera R 56 Flutiform TM 56 bazedoxifene 56 MethyPatch 56 Phase 1a 56 Allovectin 7 56 Menerba 56 phase IIa clinical 56 OLEPTRO TM 56 AZILECT R 56 Dyloject 56 Intermezzo ® 56 MERLIN TIMI 56 LUVOX CR 56 Vilazodone 56 MAXY alpha 56 PRX # 56 generation purine nucleoside 56 OraTest 56 Xibrom QD 56 lintuzumab 56 LIALDA 56 Acetavance TM 56 pixantrone NDA 56 GLP toxicology 56 crofelemer 56 TMC# [002] 56 ATryn ® 56 Horizant 56 SNT MC# 56 Phase IIa clinical 55 brivaracetam 55 carcinogenicity study 55 clinical trial 55 pivotal Phase 55 sevelamer carbonate 55 FACTIVE R gemifloxacin 55 OMAPRO 55 Prestara 55 Ceplene 55 tanespimycin 55 TELINTRA 55 FOLOTYN ® 55 Emezine 55 Linjeta TM 55 Pivotal Phase III 55 Vivitrex 55 pralatrexate 55 Clolar 55 Nasulin 55 PA# [002] 55 HuMax CD4 55 phase 2a 55 pivotal bioequivalence 55 Allovectin 7 R 55 Cloretazine R VNP#M 55 Sulonex 55 ADVANCE PD 55 Phase 1b dose escalation 55 Exocrine Pancreatic Insufficiency 55 ezogabine 55 UPLYSO 55 Phase 2b clinical trials 55 denufosol 55 FavId 55 CHMP recommendation 55 StaphVAX 55 ANDA filings 55 Anturol 55 methylnaltrexone 55 Sanctura XR 55 nalbuphine ER 55 Phase 2a clinical 55 successfully commercialize Iluvien 55 BEXXAR 55 tezampanel NGX# 55 THALOMID 55 lomitapide 55 Files Investigational 55 Firazyr 55 velaglucerase alfa 55 Onrigin 55 EMBEDA ™ 55 ARIKACE 55 subcutaneous formulation 55 LibiGel Phase III 55 MoxDuo IR 55 Onco TCS 55 PRECISE Trial 55 Cimzia TM 55 PANVAC VF 55 Troxatyl 55 AERx iDMS 55 Rhucin ® 55 ZOLINZA 55 Dacogen 55 Premarket Approval Application 55 Telavancin 55 ofatumumab HuMax CD# 55 Flutiform 55 oral methylnaltrexone 55 Phase lll 55 Thelin TM 55 Plenaxis R 55 ASONEP 55 Zensana TM 55 INT# [002] 55 atacicept 55 voreloxin 55 Onsolis 55 JANUVIA 55 Soliris TM eculizumab 55 Augment Injectable 55 albinterferon alfa 2b 55 NEBIDO R 55 FACTIVE 55 MEND CABG II 55 multiple ascending dose 55 Trexima 55 Rhucin R 55 Biologics Licensing 55 NitroMist TM 55 oral prodrug 55 TOLAMBA 55 AIMM trial 55 PROVENGE sipuleucel T 55 ITAX 55 Synavive 55 RHUCIN 54 Orazol 54 Plicera 54 StaphVAX R 54 dose cohort 54 Prestara TM 54 eniluracil 54 iloperidone 54 ALVESCO HFA 54 naproxcinod 54 multicenter Phase 54 Panzem R 54 BCX# 54 Cladribine Tablets 54 FlutiformTM 54 REPLAGAL 54 Elagolix 54 PXD# 54 indiplon 54 Zenvia Phase III 54 XIAFLEX 54 obatoclax 54 ferumoxytol 54 PSN# [002] 54 Zingo TM 54 inhaled formulation 54 L BLP# 54 INCB# [001] 54 otelixizumab 54 linaclotide 54 dextromethorphan quinidine 54 postapproval 54 Pruvel 54 Spiegelmer ® 54 UVIDEM 54 MOZOBIL 54 initiate Phase 1b 54 XiDay 54 Gabapentin GR 54 clofarabine 54 initiate Phase 54 Lialda 54 fostamatinib 54 phase IIb study 54 mesylate tablets 54 MK #A [001] 54 NovaDel 54 Loramyc 54 Preos 54 COMFORT II 54 TEMSO 54 ELADUR 54 Sulonex TM 54 Roflumilast 54 ZEGERID Powder 54 Virulizin R 54 unblinding 54 PRECISE trial 54 ALN PCS 54 Act PDUFA date 54 Urocidin TM 54 Proellex TM 54 ATPace TM 54 Ostarine 54 IMGN# 54 Phase 1b clinical 54 COLAZAL 54 Relovair 54 incyclinide 54 initiate Phase 2b 54 dose escalation trial 54 Ventavis 54 oral cladribine 54 FIRMAGON R 54 Phase Ib clinical 54 BrachySil 54 inhaled liposomal ciprofloxacin 54 CYCLOSET 54 prGCD 54 JZP 54 Itopride 54 BEMA Buprenorphine 54 ONTAK 54 Krystexxa 54 Viramidine 54 EmbraceAC 54 Silenor NDA 54 AEG# 54 Camvia 54 HGS# 54 LUCASSIN 54 CINTREDEKIN BESUDOTOX 54 AeroLEF 54 enzastaurin 54 Mepact 54 LEVADEX 54 TRISENOX 54 Exelbine NDA 54 Ketotransdel ® 54 Azedra 54 GetGoal Phase III 54 PHX# 54 PREGNANT Study 54 Evoltra 54 Silenor 54 CIMZIA TM 54 omiganan 54 Dextofisopam 54 pafuramidine 54 Neurodex TM 54 OvaRex ® MAb 54 Anthim 54 BLA 54 OROS R Hydromorphone 54 daily tramadol 54 M Enoxaparin 54 JZP 6 54 Testosterone MDTS ® 54 Phase 1a clinical 54 efficacy endpoint 54 Panzem R NCD 54 APEX PD 54 Zalbin 54 Diamyd ® 54 Phase III Pivotal 54 Phase III LibiGel 54 Jerini 54 Bydureon 54 ATL# [001] 54 linagliptin 54 Serada 54 Evoltra R 54 Fibrillex TM 54 Feraheme 54 IND 54 Saforis 54 ALGRX 54 CORTOSS 54 Restanza TM 54 TACI Ig 54 Alvesco R 54 Approvable Letter 54 mifamurtide 54 FDA Investigational Device 54 injectable formulation 54 Androxal 54 Satraplatin 54 candidates Dyloject TM 54 ALTU 54 pseudobulbar affect PBA 54 Iluvien 54 rNAPc2 54 METOZOLV ODT 54 clinical trials 54 GATTEX TM 54 PROMACTA 54 DCCR 54 Viviant 54 opioid induced bowel dysfunction 54 TREANDA 54 Phase #b/#a clinical 54 postoperative ileus POI 54 R#/MEM # 53 Fentanyl TAIFUN R 53 Complete Response letter 53 Oglemilast 53 AP# [003] 53 Kynapid 53 vosaroxin 53 BEMA Fentanyl 53 Pirfenidone 53 Keflex 53 initiate Phase Ib 53 PULSYS 53 arzoxifene 53 DPP4 inhibitor 53 severe gastroparesis 53 PDUFA 53 rhC1INH 53 SCOLR Pharma 53 telaprevir 53 MEPACT 53 Omigard TM 53 Dalbavancin 53 initiate Phase 2a 53 tramiprosate ALZHEMED TM 53 NADiA ProsVue 53 Cetrorelix 53 Triolex 53 ganetespib 53 CR# vcMMAE 53 FRDA 53 Lamictal ODT 53 Fortigel 53 Traficet EN 53 Rezular 53 velafermin belinostat 53 HspE7 53 Oracea TM 53 avanafil 53 IMA# 53 AZILECT ® 53 AzaSite 53 Phase #b/#a trial 53 Fampridine SR 53 Phase 2b kidney transplant 53 IL# PE#QQR 53 Tezampanel 53 FOLOTYN 53 Ophena TM 53 Archexin 53 BRILINTA 53 picoplatin 53 danoprevir 53 Ranexa 53 SEASONIQUE 53 Phase Ia 53 Extavia 53 Ofirmev 53 CDP# 53 Phase II 53 omacetaxine 53 Topical Interferon Alpha 2b 53 Ceflatonin 53 Targretin capsules 53 Benlysta belimumab 53 carfilzomib 53 Drug Submission 53 Premarket Approval 53 oral formulation 53 ILUVIEN ® 53 RezularTM 53 desvenlafaxine 53 prodrug stimulant 53 Tarceva TM 53 bardoxolone 53 AQ4N 53 markets HP Acthar 53 Synvisc One 53 ZEVALIN ® 53 Genasense ® oblimersen 53 abiraterone acetate 53 custirsen 53 ENTEREG ® 53 Rotarix ® 53 reslizumab 53 rhThrombin 53 aflibercept 53 Phase III HEAT 53 Phase III TRIST 53 Fentanyl Taifun 53 INKP 53 cethromycin 53 ONGLYZA ™ 53 AVINZA 53 Frova R 53 Biological License Application 53 Phase IIIb 53 AVADO 53 Hematide ™ peginesatide 53 Onrigin TM 53 JOULFERON 53 GLPG# 53 ongoing Phase 1b 53 Surfaxin LS 53 IND CTA 53 Nascobal 53 ELACYT 53 investigational humanized monoclonal antibody 53 budesonide MMX Phase III 53 budesonide MMX 53 cetrorelix 53 Amrubicin 53 bifeprunox 53 SYCREST 53 carcinogenicity studies 53 Stimuvax R 53 ELND# 53 SAR# [002] 53 adipiplon 53 selective androgen receptor modulator 53 URG# 53 IV acetaminophen 53 Luvox CR 53 Aurexis 53 TQT study 53 GAMMAGARD 53 metastatic hormone refractory 53 Entereg 53 dose escalation Phase 53 dosing cohorts 53 omacetaxine mepesuccinate 53 FOSRENOL 53 TBC# 53 Alnara 53 TYGACIL 53 LymphoStat B 53 PRIMO CABG 53 approvable letter 53 sapacitabine 53 IV APAP 53 subcutaneously administered 53 EOquin TM 53 sodium Injection 53 Arikace 53 DPX Survivac 53 Genasense R oblimersen 53 Cinryze TM 53 CLIRS trial 53 Lenocta TM 53 randomized Phase IIb 53 diarrhea predominant irritable 53 RAPAFLO 53 Ruconest 53 Optiquel ™ 53 safflower produced 53 DASISION 53 dose escalation 53 DAYTRANA TM 53 phase IIb III 53 Phase #/#a trial 53 HZT 53 trastuzumab DM1 T DM1 53 Genz # 53 HEPLISAV 53 placebo controlled clinical trials 53 ACAPODENE 53 IoGen 53 CEQ# 53 OLpur TM H2H 53 Asentar 53 Ozarelix 53 EDEMA3 53 glufosfamide 53 LUVENIQ 53 ILLUMINATE 53 Cinryze 53 rALLy clinical trial 53 Aerosurf 53 milnacipran 53 Zenvia 53 GED aPC 53 Phase III Clinical Trials 53 aclidinium bromide 53 GSK# [001] 53 Metformin GR 53 EVIZON TM squalamine lactate 53 ANDAs 53 subcutaneous RELISTOR 53 ARCOXIA 53 Opana ER 53 Silenor ® 52 granted Ortec 52 anticancer compound 52 TREDAPTIVE 52 Contrave NDA 52 orBec 52 Nuvion 52 BAY #-# 52 ORENCIA ® 52 HCD# [002] 52 eprodisate KIACTA TM 52 CAMPATH 52 APF# Phase 52 glucokinase activator 52 MGN# 52 vinflunine 52 Urocortin 2 52 RSD# oral 52 Phase Ib clinical trials 52 lucinactant 52 VQD 52 Pimavanserin 52 Glumetza 52 elagolix 52 OvaRex R 52 AFRESA 52 Xinlay 52 amifampridine phosphate 52 Tyvaso 52 tiapamil 52 forodesine hydrochloride 52 Allovectin 7 ® 52 placebo controlled Phase III 52 edoxaban 52 perifosine 52 initiate Phase IIa 52 lesinurad 52 docetaxel Taxotere R 52 Velcade bortezomib 52 acyclovir Lauriad R 52 Cloretazine ® 52 hoFH 52 Stedivaze 52 Lymphoseek ® 52 file INDs 52 PNP inhibitor 52 LUMINATE 52 Elestrin 52 Pixuvri 52 Gestiva ™ 52 ULTRASE 52 daclizumab 52 Gestiva TM 52 CAELYX 52 tasimelteon 52 Tekturna HCT 52 vidofludimus 52 telavancin 52 LAF# 52 BROMDAY 52 torsemide ER 52 BEMA ™ 52 paliperidone palmitate 52 regorafenib 52 Neo Urinary Conduit 52 ularitide 52 virus HCV protease inhibitor 52 Azilect ® 52 Solzira 52 Phase III Clinical Trial 52 Fx #A 52 APEX AMI trial 52 OncoVEX GM CSF 52 Loramyc R 52 Capesaris 52 supplemental biologics 52 bevasiranib 52 EDEMA4 52 WILEX 52 miconazole Lauriad ® 52 MAGE A3 ASCI 52 QAB# 52 XmAb# 52 TRANSDUR Bupivacaine 52 SinuNase 52 nab paclitaxel 52 Evoltra ® 52 Entereg R 52 ISENTRESS 52 refractory Hodgkin lymphoma 52 Clinical Trial Application 52 Jevtana 52 Aphthasol R 52 New Drug IND 52 histone deacetylase HDAC inhibitor 52 HFA MDI 52 CUBICIN 52 Centralized Procedure 52 AMPAKINE CX# 52 CRD5 52 midstage trials 52 AMRIX 52 Focalin XR 52 DDP# 52 intravenous formulation 52 eltrombopag 52 FROVA 52 Relistor 52 Oral Suspension #mg 52 Locteron ® 52 Leukine 52 VALSTAR 52 placebo controlled clinical 52 vinorelbine emulsion 52 oritavancin 52 Natroba 52 ALVESCO R 52 pharmacokinetic PK 52 Argatroban 52 EGRIFTA TM 52 LibiGel NDA 52 CCX# 52 OLEPTRO 52 formoterol fumarate 52 taliglucerase alfa 52 unblind 52 AMEVIVE 52 Thorough QT 52 Guanilib 52 arsenic trioxide injection 52 Emselex 52 Phase III confirmatory 52 ixabepilone 52 Firdapse 52 APTIVUS 52 Esbriet 52 REMOXY R 52 dacetuzumab 52 Hedgehog antagonist 52 mGluR5 negative 52 Chemophase 52 EMBEDA 52 Glybera 52 SUTENT ® 52 Vertex Pharma 52 Increlex R 52 tecarfarin 52 Trofex 52 Somatuline R Depot 52 orally administered 52 Technosphere Insulin 52 oral rivaroxaban 52 Targretin 52 GATTEX 52 eprodisate Fibrillex TM 52 inhaled antibiotic 52 Clevudine 52 Cutanea Life Sciences 52 Viibryd 52 IPLEX 52 retigabine 52 Viprinex TM 52 LEP ETU 52 Cimzia ® certolizumab pegol 52 Junovan TM 52 Lixisenatide 52 Bezielle 52 Afresa 52 Divalproex Sodium 52 CLARITY study 52 HoFH 52 ambrisentan 52 ISO Vorin TM 52 pirfenidone 52 Pivotal Phase 52 SinuNase TM 52 ataluren 52 Ketotransdel TM 52 Qnexa 52 PRTX 52 intravenous acetaminophen 52 Zenpep 52 ALN RSV# 52 relapsed refractory multiple myeloma 52 investigational 52 PTH1 52 Act PDUFA 52 Iluvien ® 52 nonclinical studies 52 FACTIVE tablets 52 Santhera 52 BAL# [002] 52 KNS # 52 LEVADEX ™ 52 MIRCERA 52 belinostat 52 ACUROX ® 52 lorcaserin Phase 52 AIM HIGH 52 Locteron 52 MAP# 52 ANDA submission 52 Soliris eculizumab 52 midstage studies 52 Virulizin ® 52 Cangrelor 52 SPD# 52 Personalized Immunotherapy 52 clinical pharmacology studies 52 FM VP4 52 PROPEL trial 51 randomized Phase 51 nasal calcitonin product 51 Indiplon 51 antibody MAb 51 Orphan Drug Designation 51 Azedra TM 51 maximally tolerated dose 51 metoprolol succinate 51 ACUROX 51 Captisol enabled 51 Cethrin 51 Linjeta 51 RELISTOR 51 Rescula 51 ARIKACE ™ 51 DAVANAT ® 51 exenatide once 51 dosing cohort 51 Rotarix R 51 Oral Suspension 51 cangrelor 51 dose escalation clinical 51 RANK Ligand inhibitor 51 ThermoDox ® 51 balsalazide disodium 51 Xanafide 51 Galvus 51 POSIDUR TM 51 budesonide foam 51 MAXY G# 51 apricitabine 51 liver resection surgeries 51 Balaglitazone 51 Ceplene TM 51 Rapaflo 51 TLK# 51 FUSILEV 51 MEK inhibitor 51 Fabry Disease 51 SUPPRELIN R LA 51 Pafuramidine 51 Ferumoxytol 51 Prolacria 51 SAR# [004] 51 ocrelizumab 51 zileuton IV 51 Lumizyme 51 silodosin 51 Simulect 51 Cutanea 51 CRx 51 Fortical R 51 Pegloticase 51 Inhalation Solution 51 SinuNase ™ 51 DAVANAT R 51 Orapred ODT 51 PNT#

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