ANDA applicant

Related by string. * anda . andas . AND DAD . ANDAs . Anda : Anda Chu Staff . Anda Ramat Hasharon . spokesman Bela Anda . Drug Application ANDA . ANDA abbreviated . ANDAs abbreviated / APPLICANTS . APPLICANT . appli cants . Applicants . Applicant . applicants : Rollover Applicants . Eligible applicants . RTI applicant . Suitable applicants . Successful applicants . Qualified applicants * *

Related by context. All words. (Click for frequent words.) 69 ANDA containing 65 ANDA filer 64 Barr ANDA 63 Para IV 63 Impax generic 62 Paragraph IV certification 61 Paragraph IV 61 T Pred 60 GRALISE 60 ANDA 60 Orapred ODT 60 pantoprazole sodium 60 Teva ANDA 60 DORIBAX 59 Pennsaid R 59 Hatch Waxman Act 59 Drug Application 59 Betaseron ® 59 Zolpimist 58 Periostat 58 HepaGam B 58 Anchen 58 InvaGen 58 SEASONALE 58 ANDAs 58 Biological License Application 58 Glumetza TM 57 generic Lipitor 57 CIP TRAMADOL ER 57 invalid unenforceable 57 supplemental biologics 57 Biaxin XL 57 metoprolol succinate 57 Nasacort 57 OTC monograph 57 Pliaglis 57 Entocort 57 Emend 57 Drug Applications ANDAs 57 Hatch Waxman Amendments 57 Enjuvia 57 ANDA filings 57 generic Lovenox 57 generic Prilosec 57 ATPace 57 Wellbutrin XL R 57 Tekturna HCT 57 Omnitrope 57 donepezil hydrochloride 57 sumatriptan injection 57 ANDA submission 57 Fortovase 57 ZEGERID Capsules 57 anidulafungin 57 bioequivalency 57 Citizen Petition 57 ULTRASE 57 reexamination proceeding 57 EMBEDA 57 bioequivalent versions 56 Coreg CR 56 amlodipine besylate 56 Omeprazole 56 Sanofi Aventis Allegra 56 Upsher Smith 56 Anidulafungin 56 Metformin HCl 56 PhosLo 56 Actavis Elizabeth 56 CorePharma LLC 56 Stedesa 56 Caduet 56 Daytrana ® 56 Vfend 56 Synerx Pharma 56 Cesamet 56 telavancin NDA 56 Doryx 56 Lupin Pharmaceuticals Inc. 56 NanoCrystal Technology 56 pancreatic enzyme 56 Nascobal 56 MK #B 56 FFDCA 56 Zensana 56 BiDil XR 56 Metoprolol Succinate 56 Gynazole 1 56 generic Copaxone 56 Voraxaze 56 Amphastar 56 BRILINTA 56 Synerx 55 Amrix 55 SOLODYN 55 Kynapid 55 nonsedating antihistamine 55 Sular formulation 55 SOLODYN R 55 Oxandrin 55 Altoprev 55 Purepac 55 Reloxin 55 Premarket Approval 55 Paragraph IV certifications 55 Pulsys 55 INKP 55 Zenpep 55 Dexilant 55 Tindamax 55 Argatroban 55 capsule formulation 55 CERVARIX R 55 Cobalt Pharmaceuticals 55 Noroxin 55 Wellbutrin SR 55 Intellipharmaceutics 55 GRAS notification 55 pediatric exclusivity 55 Sinol M 55 Cubicin 55 Cladribine 55 Anchen Pharmaceuticals Inc. 55 balsalazide disodium 55 casopitant 55 generic gabapentin 55 Exelbine NDA 55 Ondansetron 55 vaccine RotaTeq 55 PROVIGIL 55 Fortical R 55 Opana ER 55 Visicol 55 WHO prequalification 55 Cabilly II 55 Daytrana ™ 55 clopidogrel bisulfate 55 Aplenzin 55 generic Protonix 55 Lilly Evista 55 budesonide inhalation suspension 55 therapeutically equivalent 55 SEASONIQUE 55 DexaSite 55 Teva Pharmaceuticals USA 55 midodrine 55 Cefprozil 55 orally disintegrating 55 rabeprazole sodium 55 NitroMist 55 Dabigatran etexilate 55 Ultram ER 55 Altabax 55 gabapentin capsules 54 Exocrine Pancreatic Insufficiency 54 Glucophage XR 54 Pruvel 54 Synera 54 Dalbavancin 54 UCB Keppra 54 Novartis Galvus 54 PLAVIX ® 54 Fortamet 54 Cellegesic 54 orally disintegrating tablets 54 TRISENOX ® 54 Paragraph IV Certification 54 Ultracet R 54 Hatch Waxman litigation 54 Frova ® 54 Nicomide 54 Apotex generic 54 zafirlukast 54 Valganciclovir 54 BuSpar 54 Focalin XR R 54 AstraZeneca Toprol XL 54 generic Ovcon 54 approvable letters 54 Generic Version 54 Sigmapharm 54 Remodulin 54 Zegerid OTC 54 Announces Tentative Approval 54 ZEGERID Chewable Tablets 54 Certriad 54 Factive 54 Hycamtin 54 Bionutrics 54 Onsolis 54 MethyPatch 54 generic Norvasc 54 injectable formulations 54 Hatch Waxman 54 TOPROL XL 54 Famvir 54 Solzira 54 Zirgan 54 Exalgo TM 54 Glumetza 54 SPARLON 54 Brinavess 54 ETHEX 54 Valacyclovir 54 Emezine 54 GlaxoSmithKline Imitrex 54 AstraZeneca Toprol 54 SILENOR 54 Reloxin R 54 Par Pharmaceuticals 54 orBec R 54 Exelbine 54 Synthon 54 Marketing Authorisation Application 54 Sanctura XR 54 MoviPrep 54 alfuzosin hydrochloride 54 Octreolin 54 Lovaza TM 54 Emezine R 54 bioequivalent 54 Fenofibrate 54 PROTONIX 54 Marketing Authorization 54 LUVOX CR 54 k Premarket Notification 54 Zegerid 54 EXALGO 54 Teva Pharma 54 fluvoxamine maleate 54 Sycrest 53 Stavzor 53 enoxaparin sodium injection 53 Dexamethasone Sodium Phosphate Injection 53 Requip XL 53 Daytrana TM 53 Linjeta 53 loratadine 53 AstraZeneca Prilosec 53 KV Pharma 53 CHMP recommendation 53 therefore therapeutically equivalent 53 granisetron formulated 53 PMPRB 53 Complete Response 53 qui tam relator 53 Doribax 53 sumatriptan succinate tablets 53 repaglinide 53 HepeX B 53 biogeneric 53 oxaliplatin injection 53 SEASONALE R 53 XIBROM 53 Impax Labs 53 Zyflo CR 53 Ciclesonide 53 Xenazine ® 53 Focalin XR ® 53 generic Adderall XR 53 NeutroSpec 53 Applications ANDA 53 Allegra ® 53 Treximet 53 Renvela 53 Astelin 53 KYNAPID 53 Amlodipine Besylate 53 Periostat R 53 Junovan 53 fentanyl transdermal system 53 successfully commercialize Iluvien 53 Biologic License Application BLA 53 amlodipine maleate 53 Risperidone Oral Solution 53 Gestiva TM 53 hydrocodone formulations 53 Paragraph IV patent 53 Carbidopa Levodopa 53 Xyzal 53 BLA filing 53 liprotamase 53 pancreatic enzyme replacement 53 Azathioprine 53 5 HT3 antagonist 53 FACTIVE tablets 53 ADDERALL XR R 53 Generic Version Of 53 Fortesta 53 M Enoxaparin 53 Azactam 53 esomeprazole magnesium 53 PrevOnco 53 ANDAs abbreviated 53 Oscient 53 equivalent Reglan 53 balsalazide tablet 53 Vernakalant 53 Zenapax 53 NanoCrystal technology 53 Vimpat R 53 inter partes reexamination 53 CIP Fenofibrate 53 GLUMETZA ® 53 Besivance 53 Velac 53 Methylin 53 5mg #mg #mg 53 Comtan 53 SURFAXIN 53 LOPROX R 53 ONSOLIS 53 Exforge HCT 53 metaxalone 53 Wellbutrin XL ® 53 Bupropion HCl ER 53 Amnesteem 53 Firazyr ® 53 faropenem 53 Consent Judgment 53 CryoSeal FS System 53 Cardizem CD 53 Taclonex R 53 nonfinal 53 Arixtra 53 tolperisone 53 METOZOLV ODT 53 balsalazide 53 SPRIX ® 53 Ariad patent 53 responsive pleadings 53 Suprax 53 CoStar stent 53 SEBIVO 52 Formoterol 52 Nitrofurantoin 52 IVAX 52 Marketing Authorisation 52 authority Gurian Sherman 52 #mg capsules [002] 52 Sumatriptan Succinate Tablets 52 Ampligen r 52 Oxandrin R 52 Premarket Approval Application 52 Para IVs 52 quinapril 52 #mg #mg [002] 52 GLASSIA 52 INTUNIV TM 52 rThrombin 52 Mylan ANDA 52 #mg dosage strength 52 Biaxin 52 Master File DMF 52 Catapres TTS 52 Anzemet 52 ZapMedia applied 52 Focalin XR 52 Ustekinumab 52 Tamsulosin 52 rhThrombin 52 Proquin XR 52 Advagraf 52 Cytolin R 52 Tredaptive 52 Keflex 52 Acurox ® 52 TOCOSOL Paclitaxel 52 Mucotrol 52 SILENOR ™ 52 Alphapharm 52 Adcirca 52 CDP# 52 Aversion r Technology 52 OPANA ER 52 BioDelivery Sciences 52 oxymorphone ER 52 pixantrone NDA 52 Sanvar 52 Icatibant 52 Keppra XR 52 Orally Disintegrating Tablets 52 racemate 52 mem. op 52 CIP ISOTRETINOIN 52 dorzolamide 52 Nycomed GmbH 52 Genpharm 52 FENTORA 52 Drug Application ANDA 52 fenofibric acid 52 Drug Submission 52 Kombiglyze XR 52 Avelox 52 PDUFA Date 52 Bayer Yasmin 52 Ultracet 52 Res judicata 52 dalbavancin 52 Uroxatral 52 Rotarix R 52 Hydrochloride tablets 52 Exalgo 52 naproxen esomeprazole magnesium 52 OMNARIS 52 Benazepril 52 ZEGERID OTC 52 FDA GRAS 52 Sestamibi 52 ZOLINZA 52 Kyowa Kirin 52 FDA Modernization Act 52 Celgene Thalomid 52 Rescula 52 Soriatane 52 NRP# 52 dispositive motions 52 cefdinir 52 MEVACOR 52 HCl capsules 52 gabapentin tablets 52 Sotret 52 Barr Laboratories Inc. 52 Submits Supplemental 52 PLIVA 52 Oracea TM 52 NexACT ® 52 Detrol LA 52 Diclofenac Sodium 52 OsmoPrep 52 topical NSAID 52 Polyphenon ® E 52 dispositive motion 52 Moxatag 52 ANDA abbreviated 52 PrandiMet 52 Akela Pharma 52 Velaglucerase Alfa 52 Lamictal ODT 52 Trobalt 52 BLA resubmission 52 Tiazac 52 Zosyn 52 Replagal 52 treat GI GVHD 52 Naprelan R 52 Pulmicort Respules 52 LIALDA 52 BLA submission 52 Testosterone Gel 52 Starlix 52 RYZOLT 52 Wyeth Progenics 52 Allegra D# 52 lorcaserin NDA 52 Orally Disintegrating 52 GLP1 agonist 52 TREDAPTIVE 52 ACIPHEX 52 Femcon 52 Alvesco R 52 Akorn Strides 52 Biologics License Application 52 rotavirus vaccine Rotarix 52 Rotarix ® 52 Oracea ® 52 Fodosine 52 Shire Laboratories 52 venlafaxine hydrochloride 52 tramadol HCl 52 ProBiora3 ® 52 Levocetirizine 52 Extina 52 Doxycycline Tablets 52 Carbatrol 52 EDQM 52 DPCO 52 patent reexamination 52 Flutiform TM 52 prescription dermatological 52 CYT# QbG# 52 Sular ® 52 Sepracor patents 52 BYDUREON ™ 52 Gralise 51 tramadol ER 51 CARBOSOME 51 Nabi HB Intravenous 51 generic Lotrel 51 biogeneric drugs 51 Tyvaso 51 Pennsaid 51 Piperacillin 51 Inhalation Aerosol 51 Market Approval PMA 51 AZILECT ® 51 Vertex hepatitis C 51 Rilutek 51 Xopenex HFA 51 LibiGel NDA 51 Zebinix R 51 EpiCeram 51 TRISENOX R 51 Par Pharma 51 SYCREST 51 enoxaparin sodium 51 OLEPTRO ™ 51 dronabinol 51 Sytrinol 51 antibiotic Cubicin 51 Oral Solution 51 VISICOL R 51 Wyeth Protonix 51 Fast Track designations 51 Brovana 51 Mirtazapine 51 MAGE A3 ASCI 51 Accelerated Approval 51 ANDAs pending FDA 51 Eszopiclone 51 Rocephin 51 acitretin 51 Cefdinir 51 successfully commercialize Silenor 51 Cordarone 51 Nebido 51 Terbinafine 51 nasal calcitonin product 51 Retacrit 51 Ofirmev 51 JUVISTA 51 Teveten 51 SOLODYN ® 51 Metronidazole 51 Clindesse TM 51 ZEGERID 51 Indiplon 51 sublingual tablets 51 ADDERALL XR 51 RAPAFLO 51 Estrasorb 51 MAA submission 51 Fentanyl TAIFUN R 51 Axenohl 51 ONTAK 51 OLEPTRO 51 Zelapar 51 Surfaxin lucinactant 51 FIRAZYR 51 generic atorvastatin 51 GRAS status 51 Biologics License Application BLA 51 ELADUR 51 PULSYS 51 Replagal TM 51 Zindaclin R 51 USFDA 51 Morphine Sulfate 51 Rivastigmine 51 Relistor 51 TIMERx 51 TYGACIL 51 Somatuline R Autogel R 51 ALTACE 51 Simvastatin tablets 51 SILENOR TM 51 Tamoxifen Citrate 51 diclofenac sodium 51 Ralivia ER 51 Acular 51 Omnicef 51 Levothyroxine Sodium 51 albuterol sulfate 51 Centralized Procedure 51 AutoImmune 51 Actimmune R 51 indiplon capsules 51 Hytrin 51 Pulmicort 51 eCTD format 51 Teflaro 51 extralabel 51 Citalopram 51 USFDA approval 51 Kaletra tablet 51 Solodyn 51 AstraZeneca Nexium 51 Sanvar R 51 RECOTHROM R 51 Efudex 51 Dostinex 51 recission offer 51 BioGlue ® 51 Lipofen 51 Phospha E R 51 qui tam actions 51 NitroMist TM 51 Plavix patent 51 #D#C# 51 VALSTAR 51 Iridex 51 Ariva BDL 51 Extavia 51 NEBIDO 51 Gamunex C 51 RAZADYNE 51 BeneFIX 51 mg dosages 51 Eligard R 51 inspectional observations 51 Tygacil 51 Lidoderm 51 ANDA approvals 51 MoxDuo ® 51 postapproval 51 oxycodone HCl 51 PerClot 51 Lurasidone 51 Ticagrelor 51 Somatuline Autogel 51 Inequitable conduct 51 Captisol 51 nitrofurantoin 51 Mycograb 51 Linjeta TM 51 Femcon Fe 51 Ganciclovir 51 mg Tablets 51 Anthim 51 Vitaros 51 PreHistin TM 51 Generic Protonix 51 Nascobal R 51 moxidectin 51 Civacir 51 Ralivia TM 51 SICOR 51 subsidiary Barr Laboratories 51 XOPENEX Inhalation Solution 51 Stonewall BDL 51 desvenlafaxine 51 Rezonic 51 reexamination proceedings 51 FACTIVE R gemifloxacin 51 EGRIFTA TM 51 Ovcon 51 Ortho Cept 51 CAPHOSOL 51 UCB Cimzia 51 Effexor XR 51 IND Investigational New 51 Axid 51 OVA1 TM 51 Cardium Therapeutics TM 51 ACUROX ® 51 Meloxicam Tablets 51 Sebivo 51 REPLAGAL 51 Paladin Labs 51 Busulfex 51 generic clopidogrel bisulfate 51 Focetria 51 BEMA Fentanyl 51 biosimilar medicines 51 Mylan Receives Approval 51 Urokinase 51 granisetron hydrochloride 51 MyVax 51 IV acetaminophen 51 Estratest 51 PROVIGIL R 51 heparin vials 51 ACTIQ 51 propoxyphene containing 51 patentably distinct 50 RESTYLANE 50 spokesman Tony Plohoros 50 Aplenzin ™ 50 Velcade bortezomib 50 Fenoglide 50 granulated mesalamine 50 AcelRx 50 Agenerase 50 Skelaxin muscle relaxant 50 Teva Provides Update 50 Zolinza 50 anti emetic 50 Firazyr 50 FazaClo 50 Xolegel 50 Loxapine 50 eprodisate Fibrillex TM 50 Hatch Waxman exclusivity 50 IV APAP 50 Zanaflex Capsules 50 OvaDx 50 Ramelteon 50 Zalbin 50 Naprelan 50 Ivax Teva 50 hydrochloride capsules 50 Fexofenadine Hydrochloride 50 painkiller Valium 50 Rapaflo 50 Fortical 50 sitagliptin phosphate 50 fexofenadine hydrochloride 50 Xibrom QD 50 Actonel ® 50 F.D.A. 50 prGCD 50 Increlex TM 50 Ketotransdel 50 Rasilez HCT 50 Solzira TM 50 Emtriva Viread 50 RISPERDAL ® 50 multidose vials 50 DYSPORT 50 TNF blocker 50 Rent Stabilization Code 50 Targretin capsules 50 generic biologic 50 Stalevo 50 Ark. 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Civ 50 nonappealable 50 Zyflo 50 FIFRA 50 EMBEDA ™ 50 Ofloxacin 50 APRISO 50 Combunox 50 Abbreviated New 50 Myfortic 50 mesylate 50 Tasigna nilotinib 50 Andrx Pharmaceuticals 50 Aphthasol R 50 Levofloxacin 50 hypersensitivity allergic reactions 50 Alvesco 50 tenofovir disoproxil fumarate Viread 50 ONGLYZA ™ 50 Orathecin 50 Rule #:#-# [002] 50 Advicor 50 morphine sulfate extended 50 patent litigations 50 La.Code Crim.P. art 50 Zanamivir 50 Montelukast 50 Afresa 50 Alkaloida 50 jurisdictional prerequisite 50 Taclonex Scalp R 50 generic 50 Relieva 50 ARCOXIA 50 Mirapexin 50 Orazol 50 octreotide acetate 50 Amlodipine Besylate Tablets 50 HCl Injection 50 AERx iDMS 50 Numax 50 Elestrin TM 50 fesoterodine 50 Intermezzo ® NDA 50 Pennsaid Plus 50 Zelrix 50 GlycoGenesys 50 Pfizer Norvasc 50 Cardizem 50 Fanapt ™ 50 Cutivate 50 pulls Darvon painkiller 50 containing Paragraph IV 50 liver resection surgeries 50 Abbott Laboratories Depakote 50 Quinapril 50 atorvastatin calcium 50 InKine 50 amlodipine benazepril 50 viscosupplementation 50 Glybera R 50 bupropion hydrochloride extended 50 Thalomid 50 Trexima 50 systemic immunosuppressive drugs 50 Cycloset 50 EMSAM 50 Eligard 50 ANDA Filing 50 Nitoman 50 REMINYL ® 50 Orapred R 50 varenicline tartrate 50 ONSOLIS TM 50 bovine thrombin 50 interlocutory judgment 50 OTC ZEGERID 50 Sensipar 50 Humibid 50 ALLEGRA ® 50 pancrelipase 50 mg capsules 50 SANVAR 50 DIFICID 50 FOSAMAX PLUS D 50 CORDAPTIVE 50 Lilly Cymbalta 50 Metformin Hydrochloride 50 JANUMET 50 patentees 50 AndroGel 50 Silodosin 50 Horizant 50 DDAVP 50 Divalproex Sodium 50 generic versions 50 Enpath 50 DYNACIN R Tablets 50 cGMPs 50 Hectorol R 50 Valcyte 50 antibiotic Vancocin 50 tablets USP 50 proprietary transdermal patch 50 OFIRMEV 50 REMINYL 50 Megace ES 50 Schedule #N 50 Pentasa 50 faropenem medoxomil 50 Tekturna Rasilez 50 Roflumilast 50 Combivent 50 zileuton CR 50 Oral Suspension 50 Q#IR 50 ForsLean 50 Horizant ™ 50 XiDay 50 Zevtera 50 Octreotide 50 Sanctura 50 Oracea R 50 commercialize toremifene 50 JANUVIA 50 patent invalidity 50 DORYX 50 Medicis Pharma 50 Filgrastim 50 Indaflex TM 50 NeuroSTAT ® 50 Metvix 50 ItN 50 cephalosporins 50 Paxil CR TM 50 Xinlay 50 Pa.RAP 50 Orapred 50 Roxane Laboratories 50 Praecis 50 Biologics Licensing 50 tafamidis 50 OraTest 50 VIMOVO 50 Esomeprazole 50 FDA approvable letter 50 topical ophthalmic 50 Receives Tentative FDA 50 COLAZAL 50 ER Tablets 50 PLAVIX R 50 sumatriptan succinate injection 50 Ranexa R 50 MCPP 50 Cefazolin 50 Onco TCS 50 Marketing Authorisation Application MAA 50 PDUFA Prescription Drug 50 ALZA 50 ISTODAX 50 MONOVISC 50 iCeutica 50 Lorqess 50 Ariva BDL TM 50 EOquin 50 Fanapt TM 50 APF# 50 ELEVESS 50 sumatriptan DosePro 50 Extended Release 50 HYZAAR 50 Uracyst ® 50 TRANSDUR Bupivacaine 50 APP STORE 50 Oracea 50 APTIMA HPV assay 50 topical non steroidal 50 Dynepo TM 50 Schweizerhall 50 Lipocine 50 Alphagan P 50 Paragraph IV Notice 50 granted Ortec 50 Sitagliptin 50 approvability 50 Kaletra lopinavir ritonavir 50 bioequivalence 50 BioNeutral antimicrobial formulations 50 Approvable 50 recombinant thrombin 50 inhalation aerosol 50 protected biomaterial 50 UDL Laboratories 50 Iluvien ® 50 Gestiva 50 Expedited Review 50 Lamivudine 50 Propoxyphene 49 premarket notification 49 EGRIFTA ™ 49 CollaGenex 49 HuMax CD4 49 Mg Usa 49 panitumumab Vectibix 49 reslizumab 49 oxcarbazepine 49 ECR Pharmaceuticals 49 Claravis 49 Glucotrol XL 49 Injunctive relief 49 XYREM 49 generic Wellbutrin 49 Glucomed 49 Mircette R 49 Durezol TM 49 Vancocin 49 Prescribing Information 49 Saforis 49 Captisol enabled 49 DULERA 49 MNTX 49 Elestrin 49 cinacalcet HCl 49 Renvela ® 49 Ortho McNeil Janssen 49 Polymer Microspheres 49 Adventrx 49 Felodipine 49 Loramyc ® 49 Genelabs 49 Omnaris 49 La. RS #:# [002] 49 Prilosec omeprazole 49 Doryx ® 49 BYDUREON 49 ofloxacin 49 EvaMist NDA submission 49 Inspire Pharma 49 Act PDUFA guidelines 49 website www.nyandcompany.com 49 Paxil CR 49 divalproex ER 49 Nebivolol 49 Onconase 49 Pravachol pravastatin 49 Cabilly patent 49 OMNARIS Nasal Spray 49 Tostrex 49 Zemplar 49 tamsulosin hydrochloride 49 Cenestin 49 PrevOnco ™ 49 lesinurad 49 SmPC 49 Product Characteristics 49 Lilly Zyprexa 49 Viibryd 49 Intelence 49 DR Tablets 49 file Form #X 49 Final Judgments 49 Natroba 49 Reclast Aclasta 49 severe hypercholesterolemia 49 Gemzar ® 49 Syncria 49 Xyzal R 49 contains benzyl alcohol 49 Ark. Sup 49 UKIPO 49 Entocort EC 49 milligram dosage 49 Nasal Spray 49 Zor Pharmaceuticals 49 Boehringer Ingelheim Mirapex

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