NDAs

Related by string. NDA * * NDA convenor Sharad Yadav . NDA convener George . NDA convener . NDA Convener George . Alliance NDA . NDA submission . NDA convenor George . NDA convenor . NDA Convenor George . Investigational NDAs . NDA Convenor . Alliance NDA convenor . erstwhile NDA . lorcaserin NDA . Intermezzo ® NDA . NDA resubmission . Drug Applications NDAs . NDA Submission *

Related by context. All words. (Click for frequent words.) 58 INDs 55 ANDAs 55 Disclosure Agreements 55 approvable letters 53 nondisclosure agreements 52 biogeneric 52 molecular entities NMEs 50 Applications ANDA 50 Para IV 50 postapproval 49 Drug Applications NDAs 49 BRILINTA 48 sNDAs 48 GRALISE 48 Biologics License Application 48 Biologics Licensing 48 ANDAs pending approval 48 License Agreements 48 Certriad 48 faropenem 47 balsalazide tablet 47 pediatric exclusivity 47 lasofoxifene 47 SILENOR 47 DMFs 47 patents 47 Linjeta TM 47 Drug Applications ANDAs 47 Paragraph IV 47 BLA filing 47 ANDA filings 47 Biologics License Application BLA 47 generic Lovenox 47 biosimilar 47 Coreg CR 47 indiplon capsules 46 Tekturna Rasilez 46 Orapred ODT 46 ANDA approvals 46 Opana ER 46 ANDAs abbreviated 46 Treximet 46 Flutiform TM 46 ICH guidelines 46 clinical trials 46 BLAs 46 rolling Biologics License 46 topical diclofenac 45 NDA submission 45 eCTD submissions 45 Hatch Waxman Amendments 45 PMAs 45 AERx iDMS 45 Cellegesic 45 Exelbine 45 Cladribine 45 ANDA applicant 45 metoprolol succinate 45 CIP TRAMADOL ER 45 TQT study 45 Indiplon 45 SEASONALE 45 ANDA 45 Pennsaid R 45 Strativa 45 Advagraf 45 PrevOnco 45 PREOS R 45 Ondansetron 45 Biologic License Application BLA 45 Synerx 45 Zalbin 45 Open Specification Promise 45 NDA 45 AzaSite Plus 45 Altoprev 45 ATryn ® 44 eligen R technology 44 oxymorphone ER 44 Voraxaze 44 Horizant 44 outlicensing 44 Somatuline R Autogel R 44 ondansetron 44 Anidulafungin 44 entity NCE 44 Loramyc ® 44 Cabilly patent 44 rThrombin 44 Para IVs 44 Confidentiality Agreements 44 ANDA abbreviated 44 SURFAXIN 44 ruxolitinib 44 Biologic License Application 44 InvaGen 44 Marketing Authorization Applications 44 alvimopan 44 biosimilars 44 CIP ISOTRETINOIN 44 clopidogrel bisulfate 44 telavancin NDA 44 Ralivia ER 44 methylnaltrexone 44 Emend 44 Trizytek 44 IND Investigational New 44 BENLYSTA 44 BLA submission 44 Ereska 44 EULAs 44 Lodsys patents 44 alogliptin 44 Nebido 43 Captisol enabled 43 ASACOL 43 Glumetza TM 43 biosimilar versions 43 Solzira 43 Omnitrope 43 eprodisate Fibrillex TM 43 sNDA filing 43 adenosine injection 43 Factive 43 AzaSite Xtra 43 cGMPs 43 generic biologic 43 T Pred 43 Aphthasol R 43 Afresa 43 zileuton CR 43 generic Copaxone 43 Stavzor 43 Oracea TM 43 INTUNIV TM 43 patent 43 eligen ® 43 divalproex ER 43 BugOil R 43 postmarketing surveillance 43 PDUFA date 43 Proquin XR 43 PLK1 SNALP 43 IND submission 43 Lupin Pharmaceuticals 43 biogeneric drugs 43 PROTONIX 43 Ariad patent 43 USFDA approval 43 vemurafenib 43 Encysive Pharmaceuticals Nasdaq ENCY 43 Viviant 43 CRLs 43 SYCREST 43 enoxaparin sodium injection 43 TRANSDUR Bupivacaine 43 Zensana 43 genericized 43 Application BLA 43 ISIPublisher 43 Fortamet 43 Celgene Thalomid 43 Stedesa 43 Biologics License Applications 43 silodosin 43 biobetter 43 Paragraph IV certifications 42 SFDA approval 42 Civacir 42 PROVIGIL 42 USFDA 42 Captisol 42 PLAVIX ® 42 Zebinix R 42 GPL LGPL 42 Suven 42 patent litigations 42 Oncolys 42 PMA submission 42 iloperidone 42 Orathecin 42 Provisional Patent 42 file INDs 42 PLAVIX 42 licensing agreements 42 ISO Vorin TM 42 Wellbutrin XL R 42 Requip XL 42 Novartis Galvus 42 Acurox ® 42 ASONEP 42 ANDA containing 42 COLAZAL 42 PDUFA Date 42 ZEFTERA TM Zevtera TM 42 supplemental biologics 42 Fampridine 42 SILENOR ™ 42 successfully commercialize Silenor 42 approvability 42 SBIR grants 42 Amlodipine Besylate Tablets 42 Vimovo 42 RAPTIVA 42 OTC ZEGERID 42 asenapine 42 VaxImmune 42 Market Approval PMA 42 eCTD format 42 anidulafungin 42 QbD 42 cefuroxime axetil 42 reformulates existing FDA 42 USL# 42 MyVax 42 Amlodipine Besylate 42 oxycodone HCl 42 MAAs 41 alemtuzumab MS 41 Subpart E 41 EGRIFTA TM 41 outlicensed 41 cinacalcet HCl 41 novel oral anticoagulant 41 Pruvel 41 MCPP 41 Preotact 41 Rhucin ® 41 Thelin TM 41 Marketing Authorisation Application MAA 41 Doryx 41 GPL v3 41 CDP# 41 RIGScan CR 41 Stalevo ® 41 CORLUX CORT # 41 BioThrax ® 41 Drug Submission 41 Inhaled Insulin 41 VIMOVO TM 41 Genentech Roche 41 oral taxane 41 DepoDur TM 41 Marketing Authorisation Application 41 amrubicin 41 compound KOS 41 Junovan 41 Emezine 41 Lialda 41 Lidoderm 41 FIRAZYR 41 Patent expiries 41 DepoBupivacaine TM 41 Pfizer maraviroc 41 PDUFA 41 Orphan Designation 41 Gralise 41 Sutent sunitinib 41 OLEPTRO TM 41 desvenlafaxine 41 vCloud API 41 Stelara 41 topical NSAID 41 Paragraph IV certification 41 Premarket Approval 41 Joulferon 41 Orphan Drug Status 41 patent expiry 41 Velac 41 Ditropan XL 41 Marketing Authorization Application 41 NCEs 41 VersaFilm 41 EULA 41 Rezonic 41 ATD gel 41 SEASONIQUE 41 Dacetuzumab 41 Investigational 41 DORYX 41 injectable formulations 41 Seikagaku Corporation 41 Fast Track designations 41 REMS 41 Apricus Bio 41 Glucophage XR 41 Fortical R 41 ecallantide 41 Nalmefene 41 Subpart H 41 Abstral ® 41 MethyPatch 41 Intravenous Hepatitis B 41 M Enoxaparin 41 FDA Accepts 41 Restoraderm R 41 Omigard 41 Vitaros 41 Lupuzor 41 Nycomed GmbH 41 Flutiform 41 Enjuvia 40 AtuRNAi 40 Chemical Entity NCE 40 bio similars 40 SEASONALE R 40 Dostinex 40 Argatroban 40 Investigational Device Exemption 40 Vitaros R 40 Glumetza 40 Paragraph IV Certification 40 Paragraph IV Notice 40 Dexilant 40 Salix Pharma 40 EGRIFTA ™ 40 rALLy trial 40 PDE4 inhibitors 40 esomeprazole magnesium 40 PRAVACHOL R 40 sNDA 40 nasal calcitonin product 40 Emselex 40 miRNA therapeutics 40 GPR# agonist 40 Seroquel XR 40 Rotarix ® 40 ACIPHEX 40 MK #B 40 ABILIFY ® 40 Betaseron ® 40 EPIX Pharmaceuticals 40 Zegerid OTC 40 Expedited Review 40 5 lipoxygenase inhibitor 40 Confidentiality agreements 40 lorcaserin NDA 40 ANDA filer 40 LX# LX# LX# 40 Vibativ 40 Captisol ® 40 Asentar TM 40 Contrave NDA 40 intellectualproperty 40 Symbian Signed 40 Targretin capsules 40 Fast Track designation 40 Somatuline Autogel 40 Arxxant 40 generic 40 OTC proton pump 40 Ceragenix 40 glucokinase activator 40 Mirapexin 40 GPL2 40 cycle oral contraceptive 40 Inderal LA 40 Biosimilars 40 postmarketing studies 40 tramiprosate ALZHEMED TM 40 Lovaza TM 40 commercialized DURECT 40 Entereg TM 40 Panzem R NCD 40 Daytrana TM 40 Accelerated Approval 40 biosimilar medicines 40 NitroMist TM 40 Lupin Pharmaceuticals Inc. 40 Pillar5 40 APF# NDA 40 FACTIVE tablets 40 Targeted Chemotherapy 40 ZEGERID Chewable Tablets 40 HCV protease inhibitors 40 gabapentin enacarbil 40 Entocort 40 vilazodone 40 ANDA Filing 40 Supplemental Biologics License Application 40 UCB Cimzia 40 UCB Keppra 40 OFIRMEV 40 Mepact 40 Oracea 40 QAB# 40 anti emetic 40 VANTAS 40 RCEs 40 gepirone ER 40 Suprax 40 RECOTHROM R 40 ONGLYZA ™ 40 Milestone Payments 40 Sanctura 40 OMAPRO ™ 40 Alza Corporation 40 Nanobodies 40 Metoprolol Succinate 40 IND CTA 40 Nascobal 40 Fortical 40 UCB Cimzia ® 40 ACUROX ® 40 Evoltra ® 40 Exalgo TM 40 sNDA submission 40 MHLW 40 ONGLYZA TM 40 k Premarket Notification 39 VIMOVO ™ 39 oral cladribine 39 Orphan Drug designations 39 palonosetron 39 noncompetes 39 ONSOLIS ™ 39 confidentiality agreements 39 Tyzeka Sebivo 39 dipeptidyl peptidase IV 39 Zyflo CR 39 Amphastar 39 Teflaro 39 Orazol 39 Frova R 39 NM# [001] 39 Phase IIa clinical trials 39 Replagal 39 RTP #i 39 OraDisc TM 39 Biophan patent 39 Fortigel 39 Intermezzo ® NDA 39 DDDPlus 39 orally disintegrating 39 Generic Version 39 Ciclesonide 39 product roadmaps 39 GlaxoSmithKline Imitrex 39 Sycrest 39 patentees 39 copywrite 39 Cefdinir 39 ACTIQ 39 AnGes 39 lixivaptan 39 Unifill syringe 39 Allovectin 7 r 39 gave Makena orphan 39 Acurox r Tablets 39 F.D.A. 39 Lipofen 39 Patents 39 GeneCards R 39 APTIMA HPV assay 39 Synera 39 NDA BLA 39 DepoMed 39 Nippon Kayaku 39 Marketing Authorisation 39 Doxycycline Tablets 39 Flutiform ™ 39 InterfeRx 39 Drug Administration USFDA 39 GastroPlus 39 Upsher Smith 39 FACTIVE 39 Zensana TM 39 Daewoong 39 Novartis Gilenya 39 Detrol LA 39 Product Designation 39 OvaRex ® MAb 39 SANCTURA XR 39 Brovana 39 sBLA 39 Cardene 39 Exelbine NDA 39 WinRho SDF 39 Hectorol R 39 Trastuzumab DM1 39 Orphan Drug 39 postmarket studies 39 Eli Lilly Cymbalta 39 Vascular Wrap TM 39 looming patent expiries 39 Acetavance TM 39 Fast Track Status 39 SPD# 39 KADIAN ® 39 Emezine R 39 5mg #mg #mg 39 NitroMist 39 New Drug Application 39 exclusivities 39 aptamer therapeutics 39 novel emulsion formulation 39 peginesatide 39 supplemental Biologics License Application 39 Sebivo 39 Plenaxis R 39 Cymbalta duloxetine 39 #D#C# 39 HepeX B 39 Cutivate 39 PhotoCure 39 FROVA 39 successfully commercialize Iluvien 39 pantoprazole sodium 39 Silenor ® 39 Amrix 39 Metvix 39 Generic Versions 39 BYDUREON ™ 39 Didronel 39 REMINYL ® 39 MorphoSys proprietary 39 Ceragenin ™ technology 39 FDA approvable letter 39 Hatch Waxman exclusivity 39 Orphan designation 39 GRAS notification 39 GLP toxicology studies 39 Genz # 39 HELSINN 39 XIENCE 39 Vfend 39 PharmaDirections 39 torezolid phosphate 39 Licensing Agreements 39 TRANSDUR ™ 39 DETERx ™ 39 Corrective Action Order 39 Anzemet 39 BCRs 39 Megace R ES 38 Syntonix 38 Neuradiab 38 Plavix patent 38 orally disintegrating tablets 38 MAXY alpha 38 CDDL license 38 Urocidin TM 38 Ofirmev 38 SOLODYN R 38 guidances 38 Fortesta 38 RYZOLT 38 IBPL 38 ALZA 38 Cladribine Tablets 38 Pennsaid Plus 38 Metformin GR 38 commercialize OncoGenex lead 38 Hedrin 38 Aceon 38 AMRIX 38 invalid unenforceable 38 FDA Orphan Drug 38 Metformin Hydrochloride 38 PDUFA Prescription Drug 38 Ambrx 38 TIMERx 38 Commercialization Agreement 38 Roche SWX ROG 38 PD2i CA 38 SCOLR 38 MoxDuo IV 38 NanoCrystal 38 DispersinB R 38 Nippon Shinyaku 38 AGPLv3 38 License Option Agreement 38 punctal plug 38 Tanabe Seiyaku 38 Schizophrenia Drug 38 Aciphex 38 Morphine Sulfate 38 Metabasis stockholders 38 Famvir ® 38 WS Notification 38 Lipocine 38 RenaZorb TM 38 Uplyso 38 repaglinide 38 tivozanib AV 38 Zor Pharmaceuticals 38 MAGE A3 ASCI 38 fesoterodine 38 rabeprazole sodium 38 Eszopiclone 38 daily Glumetza TM 38 wilate ® 38 exclusivity 38 Glatiramer Acetate 38 WHO prequalification 38 licensees 38 Victrelis 38 eSubmissions 38 blood thinner prasugrel 38 Topiramate tablets 38 generic gabapentin 38 Reloxin 38 OEMS 38 Actimmune R 38 Miacalcin 38 anti CD# antibodies 38 codevelopment 38 Adnectin 38 PROCAPS 38 Phenomix 38 NYS RN 38 Daytrana ™ 38 CHMP recommendation 38 BioSilicon TM 38 SOPs 38 Aversion r Technology 38 menadione 38 sumatriptan injection 38 Files IND 38 NasdaqGM SPPI 38 Alseres Cethrin 38 GATTEX teduglutide 38 nondisclosure agreement 38 Metricath Gemini 38 ibuprofen gel 38 citalopram hydrobromide 38 RESTYLANE R 38 fentanyl transdermal system 38 Nebivolol 38 Tostrex 38 Taiho Pharmaceutical 38 Trobalt 38 vinorelbine emulsion 38 Meda STO MEDAA 38 Dificid 38 Wellbutrin SR 38 Visian Toric ICL 38 ProQuin XR 38 DCGI 38 amlodipine besylate 38 Amgen Neupogen 38 alfuzosin hydrochloride 38 GlycoGenesys 38 Hatch Waxman 38 PD2i ® algorithm 38 VITAGEL 38 Lodsys 38 Nuedexta 38 Rapinyl 38 NESINA 38 Gleevec Glivec 38 Mylan Receives Approval 38 Bio3 Research 38 bioequivalency 38 UKIPO 38 Biosimilar 38 Increlex TM 38 Master File DMF 38 Dr. Khine 38 Biological License Application 38 Sancuso 38 Invisicare 38 SEASONIQUE R 38 Quark Biotech 38 generic Protonix 38 JUVISTA 38 SIONIX owns 38 FSPs 38 GLUMETZA ® 38 zolpidem tartrate 38 Biaxin XL 38 Centralized Procedure 38 #mg #mg [002] 38 Impax Labs 38 ELADUR TM 38 LFRP 38 humanized antibodies 38 Bayer Schering 38 SPAs 38 Estorra 38 Octreolin 38 efalizumab 38 Cardium Therapeutics TM 38 Pronova 38 Pfizer Sutent 38 EDQM 38 Orphan Status 38 Effexor XR 38 AstraZeneca Symbicort 38 RAPTIVA R 38 ZapMedia applied 38 CobOral 38 Patents Covering 38 Gestiva TM 38 Synerx Pharma 38 INTELLITAB TM 37 Bayer Onyx 37 BiDil XR 37 Bonefos 37 Cardizem R 37 generic biopharmaceuticals 37 venlafaxine hydrochloride 37 MDUFMA 37 Indaflex 37 include DSM Biologics 37 Teikoku Seiyaku 37 paliperidone palmitate 37 Pfizer Norvasc 37 Collaboration Agreement 37 ZaBeCor 37 SOLODYN 37 OPANA ER 37 Kaletra tablet 37 Sumatriptan Succinate Tablets 37 BioSante licensees 37 APP STORE 37 antisense drugs 37 Xyzal 37 granted Ortec 37 Zavesca r 37 HepDirect 37 MoxDuo 37 AMPAKINE CX# 37 Nabi HB Intravenous 37 Orapred 37 CuraGen patents 37 Confidentiality Agreement 37 HuCAL GOLD R 37 COLAZAL R 37 sumatriptan DosePro 37 Neovastat 37 sublingual fentanyl 37 SANCTURA R 37 Fexofenadine Hydrochloride 37 Investigational Drugs 37 JunJing III 37 RenaZorb 37 fusion inhibitor 37 Raptiva R 37 covering SNALP 37 Poly ICR 37 Dyax phage display 37 Antares Pharma ATD TM 37 Exorbitant salaries 37 candidate deforolimus 37 Bionutrics 37 Oasmia 37 Evoltra 37 rxRNA 37 Rexahn licensees 37 intellectual property 37 Risperidone Oral Solution 37 eprodisate KIACTA TM 37 InSight Publisher 37 CTLA4 Ig 37 pixantrone NDA 37 CLIA waiver 37 XOPENEX 37 MONOVISC 37 Paladin Labs 37 Teva ANDA 37 dalbavancin 37 AETI SEC 37 Q#IR 37 lubiprostone 37 eliglustat tartrate 37 PLAVIX R 37 easypod R 37 OMAPRO 37 DC Bead 37 GEM #S 37 Pfizer Zoloft 37 capsule formulation 37 Venlafaxine Hydrochloride 37 ESTRASORB R 37 Razadyne ER 37 Advicor 37 IMiDs 37 Egrifta 37 Certican 37 Par Pharma 37 Surfaxin LS 37 Orphan Drug designation 37 sanofi aventis SNY 37 www.vialicensing.com 37 Pre IND 37 Akorn Strides 37 Immunicon intellectual property 37 Camptosar 37 Periostat R 37 ZALBIN 37 Lauren Silvernail 37 Australian Therapeutic Goods 37 Teveten 37 Atugen 37 ELEVESS 37 Dr. Gulfo 37 REGPARA 37 Periostat 37 LentiVector technology 37 Fortovase 37 Patent Application 37 nondisclosure clauses 37 oxybutynin 37 PerClot 37 EBx ® 37 Oral BDP 37 HIV integrase inhibitor 37 Curosurf 37 Par Pharmaceuticals 37 tranilast 37 Felodipine 37 AIMM trial 37 Ecallantide 37 Bioxel 37 intellectual property rights 37 chemical entities NCEs 37 XOPENEX Inhalation Solution 37 AstraZeneca Prilosec 37 Investigational Agent 37 gets USFDA nod 37 generic biologics 37 Benazepril Hydrochloride 37 Aplenzin 37 Wellbutrin XL ® 37 urokinase 37 Receives Tentative FDA 37 Sublinox 37 proprietory 37 Paraplatin 37 donepezil hydrochloride 37 Loramyc 37 Earns Milestone Payment 37 Nexium AstraZeneca 37 AFFITOME 37 Reloxin R 37 Pravastatin 37 Kombiglyze XR 37 Prostate AdenoCarcinoma Treatment 37 LOPROX R 37 liver resection surgeries 37 sumatriptan succinate 37 iii Cubist 37 Uracyst 37 hydrophobic docetaxel prodrug nanoparticle 37 License Agreement 37 VIMOVO 37 VeroScience 37 Recothrom 37 Junovan TM 37 Dor BioPharma 37 Bayer Yakuhin 37 Zemiva TM 37 Clintrace 37 Abbreviated New 36 ATD TM gel 36 Biogenerics 36 HCl capsules 36 Thrombin topical Recombinant 36 Kosan motilin agonist 36 '# patents 36 filgrastim 36 intravenous formulations 36 BioSyent Pharma 36 INNOVIVE 36 Benazepril 36 bilastine 36 Announces Tentative Approval 36 Stavzor TM 36 Oracea ® 36 Generic Version Of 36 Merck Januvia 36 PRISTIQ 36 generic Flomax 36 Evoltra R 36 Patent License Agreement 36 deliverables 36 Enhanze 36 ACEON R 36 Impax generic 36 Drug Submission NDS 36 Zipsor 36 Intuniv 36 FIPS certification 36 OvaRex R 36 Nanobody R 36 oncolytics 36 blood thinner rivaroxaban 36 Marketing Authorization 36 Behcet uveitis 36 clinically validated targets 36 TaiGen 36 relapsed refractory pediatric 36 nonclinical studies 36 Celladon Corporation 36 PTH1 36 Caduet 36 Intermec RFID patents 36 proprietary eligen R 36 oral contraceptives Loestrin 36 SpeBio joint venture 36 equivalent Reglan 36 Hatch Waxman Act 36 PEG PAL 36 Dosage Strengths 36 Pharmos pipeline 36 NeoVisc 36 pending ANDAs 36 anti CD3 monoclonal 36 Daytrana ® 36 Testosterone Gel 36 valtorcitabine 36 ColorectAlert TM 36 NanoCrystal technology 36 FEMCON FE 36 Rivastigmine 36 custom endonucleases 36 Standards CFATS 36 Cubicin 36 Excipients 36 Zegerid 36 forodesine HCl 36 Intellectual Property Portfolio 36 HuMax CD4 36 ESTRASORB 36 MGCD# clinical trials 36 Plendil 36 miconazole Lauriad ® 36 Maxy G# 36 combinability 36 Carbatrol 36 Xenazine 36 ACEON R perindopril erbumine 36 patent expirations 36 metformin hydrochloride tablets 36 JSPA 36 prostone 36 GeoVax AIDS vaccine 36 drugs alitretinoin ceftobiprole 36 SNT MC# 36 Locked Nucleic Acid 36 LNP formulations 36 Impax ANDA 36 Marketing Authorizations 36 dosing intervals 36 #mg dosage strength 36 xi Immtech ability 36 bifeprunox 36 Fleximer R 36 generic atorvastatin 36 AstraZeneca Toprol 36 Odyssey Thera 36 generic oral contraceptives 36 postmarket safety 36 sodium glucose transporter 36 dSLIM 36 Orphan Drug status 36 Galenea 36 RECALL VAX TM 36 USPTO 36 Ortho Cept 36 India DCGI 36 visit smith.com 36 XP# XP# 36 Albugon 36 Rilutek 36 Roche Mircera 36 ZFP technology 36 gabapentin capsules 36 Transmeta patents 36 DVD6C Licensing Group 36 eCTD submission 36 Exforge HCT 36 Orphan Drug Designation 36 Time Warp patent 36 Active Pharmaceutical Ingredient 36 Solodyn 36 Spiegelmers 36 Zeneus 36 HepaGam B R 36 Valacyclovir 36 pivotal bioequivalence 36 Intellectual Property Rights TRIPs 36 encapsulates siRNAs 36 nonprovisional application 36 GNU LGPL 36 Kosmos Pharma 36 NeutroPhase TM 36 Frova 36 PATENT 36 Glassia 36 generic Lipitor 36 Accelerated Assessment 36 approvals 36 Valganciclovir 36 SOFAs 36 generic Norvasc 36 Eligard ® 36 Priligy

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