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(Click for frequent words.) 75 ANDA filings 75 ANDA 72 DMFs 72 Paragraph IV 71 ANDA approvals 70 Drug Applications ANDAs 68 Para IV 68 ANDAs pending 67 ANDAs pending approval 66 ANDA containing 65 INDs 65 Abbreviated New 65 pending ANDAs 62 USFDA approval 62 ANDAs abbreviated 62 Applications ANDA 61 USFDA 61 Paragraph IV certifications 60 Para IVs 60 Oracea 60 biosimilar 59 Paragraph IV certification 59 Biologics License Application 59 Zydus Cadila 59 ULTRASE 59 Amneal 59 Marketing Authorisation Application 59 ANDAs pending FDA 58 Glenmark 58 Ranbaxy 58 IND Investigational New 58 ANDA applicant 58 Hatch Waxman Amendments 58 Suprax 58 Trelstar R 58 SEASONALE R 58 InvaGen 57 Loramyc ® 57 ASACOL 57 Frova ® 57 Orapred ODT 57 Akorn Strides 57 Lupin Pharmaceuticals Inc. 57 ZEGERID Capsules 57 metoprolol succinate 57 Biologic License Application 57 Indoco 57 Biologics License Application BLA 57 granulated mesalamine 57 Drug Administration USFDA 57 Drug Application 57 Cefprozil tablets 57 Enjuvia 56 ANDA abbreviated 56 Levetiracetam Tablets 56 sBLA 56 approvable letters 56 SYCREST 56 Cefprozil 56 Lipofen 56 Doryx 56 BRILINTA 56 Aurobindo Pharma 56 ANDA filer 56 Zydus 56 Marketing Authorization Application 56 Omeprazole 56 Loramyc R 56 cephalosporin 56 Suven 56 MONOVISC 56 biogeneric 56 Apricus Bio 56 Interpharm 56 silodosin 56 Keppra ® XR 56 Paragraph IV Certification 55 Glumetza 55 VISICOL R 55 Chemical Entity NCE 55 Cefdinir 55 dalbavancin 55 Amlodipine Besylate Tablets 55 generic oral contraceptives 55 IBPL 55 Biological License Application 55 Wellbutrin XL R 55 Ultracet R 55 Stavzor 55 Marketing Authorisation Application MAA 55 #mg #mg [002] 55 Focalin XR ® 55 PLAVIX R 55 NDAs 55 Lidoderm R 55 Focalin XR 55 CIP TRAMADOL ER 55 molecular entities NMEs 55 sNDAs 55 Opana ER 55 Somatuline R Autogel R 55 lorcaserin NDA 55 SFDA approval 55 PROTONIX 55 Simvastatin Tablets 55 Announces Tentative Approval 55 Altoprev 55 T Pred 55 pediatric exclusivity 55 Drug Applications NDAs 55 Lyrica pregabalin 55 Rapaflo 55 NitroMist TM 55 cycle oral contraceptive 55 topical NSAID 55 Flutiform TM 55 faropenem 55 SOLODYN 55 Ceftriaxone 55 Keflex 55 AstraZeneca Toprol XL 54 Nascobal 54 SOLODYN R 54 NUVIGIL 54 patent expiry 54 Lupin Ltd 54 PMA submission 54 BENLYSTA 54 Global Generics 54 Investigational 54 SEASONIQUE 54 SEASONALE 54 ScinoPharm 54 Oracea TM 54 Wellbutrin SR 54 PREOS R 54 Joulferon 54 ABILIFY R 54 USFDA nod 54 Gynazole 1 54 Lidoderm 54 MK #B 54 Biaxin XL 54 Lotrel ® 54 Drug Submission 54 Fortical R 54 Ipca 54 enoxaparin sodium injection 54 Zenpep 54 Marketing Authorization Applications 54 RESTYLANE R 54 ONSOLIS 54 5mg #mg #mg 54 Teflaro 54 Generic Version 54 Vitaros 54 AstraZeneca Toprol 54 Alvogen 54 biologics 54 NPIL 54 GRAS notification 54 Stedesa 54 Marketing Authorization Application MAA 54 GRALISE 54 balsalazide tablet 54 Amrix 54 Lialda 54 Sotret 54 sNDA 54 LUVOX CR 54 sumatriptan injection 54 JBCPL 54 PhosLo 54 fentanyl transdermal system 54 gets USFDA nod 54 sumatriptan succinate 54 generic injectable 53 Factive 53 New Drug Application 53 Zebinix R 53 Strides Arcolab 53 Vfend 53 Ticagrelor 53 INKP 53 mg Tablets 53 fluvoxamine maleate 53 RAPAFLO 53 Ciclesonide 53 k premarket 53 Levocetirizine 53 Glenmark Generics 53 Lidoderm ® 53 Premarket Approval Application 53 Eligard ® 53 NEBIDO 53 application sNDA 53 OLEPTRO 53 Barr ANDA 53 Emezine 53 Onsolis 53 generic Allegra 53 THALOMID 53 Clindesse TM 53 Eligard R 53 Extended Release Tablets 53 ETHEX 53 Application BLA 53 Complete Response 53 Rhucin ® 53 COLAZAL 53 Alvesco 53 BLA filing 53 branded generics 53 Sumatriptan Succinate 53 generic Protonix 53 NMEs 53 Azilect ® 53 Mylan Receives Approval 53 Benazepril 53 Provisional Patent 53 Paragraph IV Notice 53 OLEPTRO ™ 53 Stalevo 53 supplemental biologics 53 PDUFA date 53 Zolpimist 53 PREOS 53 anti infective 53 Zytiga 53 ISENTRESS raltegravir 53 SILENOR 53 indiplon capsules 53 Terbinafine 53 generics 53 Natco Pharma 53 Preotact 53 CIP ISOTRETINOIN 53 Cefazolin 53 Civacir 53 TELINTRA 53 Valganciclovir 53 NDA submission 53 Shasun 53 Loramyc ™ 53 Zensana 52 mg dosage 52 ETHEX Corporation 52 CDP# 52 Biologic License Application BLA 52 GlaxoSmithKline Imitrex 52 Betaseron ® 52 Amlodipine Besylate 52 Morphine Sulfate 52 CIP Fenofibrate 52 Caraco 52 Specifar 52 Glucotrol XL 52 Pantoprazole 52 Rebif ® 52 HYZAAR 52 CRAMS 52 injectable formulations 52 alogliptin 52 Doxycycline Tablets 52 ONSOLIS TM 52 Lovaza TM 52 Abstral 52 tacrolimus capsules 52 TRANSDUR Sufentanil 52 Orathecin 52 Fenoglide 52 Soriatane 52 Frova R 52 PDE4 inhibitor 52 amlodipine maleate 52 BEMA Fentanyl 52 Treximet 52 REPLAGAL 52 oral contraceptives Loestrin 52 Intellipharmaceutics 52 INTUNIV TM 52 Azactam 52 HP Acthar R 52 Zegerid OTC 52 Par Pharma 52 Ondansetron Injection 52 Mr. Movens 52 Decapeptyl R 52 generic Toprol XL 52 Nebido 52 Dosage Strengths 52 COLAZAL R 52 Cadila Healthcare 52 Active Pharmaceutical Ingredient 52 Icatibant 52 supplemental Biologics License Application 52 generic Flomax 52 Topiramate tablets 52 PLAVIX ® 52 RhuDex ® 52 generic oxaliplatin 52 Ondansetron 52 KALBITOR ® 52 biosimilars 52 Cellegesic 52 Uracyst 52 Tiazac 52 Velac 52 Losartan Potassium 52 Fosphenytoin 52 Risperdal Consta 52 NCEs 52 RESTYLANE 52 Pexeva 52 AMRIX 52 Exocrine Pancreatic Insufficiency 52 generic Lovenox 52 severe hypercholesterolemia 52 NeoVisc 52 tramadol ER 52 Razadyne ER 52 generic Copaxone 52 Neulasta R 52 lubiprostone 52 Dalbavancin 52 OLEPTRO TM 52 Teva ANDA 52 Act PDUFA date 52 TRISENOX 52 XIFAXAN R 52 zileuton CR 52 desvenlafaxine 52 Sanctura XR 52 Replagal 52 tiapamil 52 Aloxi Injection 52 IND submission 52 TACLONEX 52 ITAX 52 RAZADYNE 52 Omnitrope 52 Daewoong 52 Sular formulation 52 Gabapentin Capsules 52 Firdapse 52 Solodyn 52 BLA submission 52 Orencia 52 generic Valtrex 52 Ultram ER 52 Rhucin 52 Testim 52 XYREM 52 lasofoxifene 52 PROVIGIL 51 Onco TCS 51 Orexo 51 FDA Approvable Letter 51 sumatriptan succinate injection 51 Oxandrin 51 Eloxatin ® 51 Oxytrol 51 Synthon 51 BYDUREON 51 Tostrex 51 Tamsulosin 51 Luveniq 51 OSMOPREP 51 Intas 51 FACTIVE R gemifloxacin 51 Argatroban 51 ALGRX 51 nasal calcitonin product 51 Gestiva TM 51 Valtropin 51 Alvesco R 51 vilazodone 51 Cubicin 51 generic Prilosec 51 Ditropan XL 51 Strativa 51 PREGNANT Study 51 Pennsaid 51 Cadila 51 Indoco Remedies 51 Levoleucovorin 51 Kyowa Kirin 51 UCB Keppra 51 IND 51 registrational 51 LUNESTA ® 51 Pfizer Lyrica 51 RYZOLT 51 acyclovir Lauriad R 51 AMITIZA R 51 Renvela 51 Piperacillin 51 ANDA Abbreviated New 51 Bupropion HCl ER 51 Lamictal ODT 51 XiDay 51 udenafil 51 Filgrastim 51 Keppra ® levetiracetam 51 Orphan Drug designations 51 Release Tablets 51 Unichem Laboratories 51 Pennsaid R 51 Cephalosporin 51 Nasacort 51 ADDERALL XR R 51 Loramyc 51 Piramal Healthcare Solutions 51 generic Lipitor 51 Zosyn 51 Oxandrin R 51 intravenous acetaminophen 51 TRELSTAR ® 51 Receives Tentative FDA 51 Generic Version Of 51 generic Lotrel 51 Sumatriptan Succinate Tablets 51 Ketotransdel 51 k Premarket Notification 51 Nitrofurantoin 51 Adcirca 51 Valacyclovir 51 AzaSite Plus 51 Oxcarbazepine 51 Alaven 51 Daytrana ® 51 PULMICORT 51 XIBROM 51 Biologics License Applications 51 albinterferon alfa 2b 51 Focalin XR R 51 dosage forms 51 Rezonic 51 Hatch Waxman Act 51 orally disintegrating 51 Exalgo 51 AstraZeneca Nexium 51 DPP4 inhibitor 51 Allegra D# 51 anidulafungin 51 #mg dosage strengths 51 BLAs 51 MAA submission 51 amlodipine besylate 51 Augment ™ 51 Lilly ICOS 51 Barr Laboratories Inc. 51 sterile injectables 51 Caduet 51 ATryn ® 51 Voraxaze 51 Divalproex Sodium 51 Drug Application ANDA 51 Lupin Pharmaceuticals 51 Effexor XR 51 Cobalt Pharmaceuticals 51 BEMA TM Fentanyl 51 Biologics Licensing 51 clopidogrel bisulfate 51 Emend 51 Pivotal Phase III 51 TREANDA 51 Aurobindo 51 Fortamet 51 LIVALO 51 Cladribine Tablets 51 Mirtazapine 51 FDA Accepts 51 Zalbin 51 morphine sulfate extended 51 ACTIQ 51 Dacogen injection 51 LIALDA 51 Xyzal 51 Vilazodone 51 Orphan Drug Designation 51 Upsher Smith 51 Cardene R 51 Felodipine 51 Ortho Cept 51 JANUVIA 51 PRAVACHOL R 51 Proquin XR 51 Taclonex 51 SCOLR 51 RECOTHROM R 51 voclosporin 51 Fentanyl TAIFUN R 51 Alkem 51 Relistor 51 Fanapt ™ 51 Oscient 51 pantoprazole 51 Metoprolol Succinate Extended Release 51 Rotarix ® 51 Santhera 51 ZEGERID R 51 Remodulin 51 LEUKINE 51 Hycamtin 51 FDA approvable letter 51 Zyflo CR 51 crofelemer 51 Generic Protonix 51 donepezil hydrochloride 51 palonosetron hydrochloride injection 51 ARCOXIA 51 Indiplon 51 Phase III trials 51 Crofelemer 50 Octreotide 50 Hatch Waxman exclusivity 50 lurasidone 50 Pruvel 50 Metformin Hydrochloride 50 Somatuline R Depot 50 RISPERDAL CONSTA 50 ZEFTERA TM Zevtera TM 50 CRINONE ® 50 Ofloxacin 50 KADIAN R 50 HepeX B 50 gabapentin capsules 50 Lannett 50 SCHWARZ PHARMA 50 PDUFA Date 50 Megace ES 50 TRANSDUR Bupivacaine 50 VALSTAR 50 Synovics 50 1mg 2mg 50 iloperidone 50 Anidulafungin 50 FIRAZYR 50 betamethasone dipropionate 50 Somatuline Autogel 50 NanoCrystal technology 50 HCl tablets 50 BioDelivery Sciences 50 AstraZeneca Symbicort 50 Inhalation Aerosol 50 Junovan 50 FlutiformTM 50 ZETIA 50 TRELSTAR R 50 DMFs globally 50 outlicensing 50 Trexima 50 REMOXY 50 biosurgical 50 tolevamer 50 oral formulations 50 Ixempra 50 Tygacil 50 bioequivalent 50 PLIVA 50 Vancocin 50 JZP 50 naproxen esomeprazole magnesium 50 IND CTA 50 Pristiq 50 Exelbine 50 Xolegel 50 OMNARIS Nasal Spray 50 Priority Review 50 Sycrest 50 RAPTIVA 50 SinuNase TM 50 Comtan 50 Fanapt ® 50 Dyloject 50 ALZA 50 Glenmark Pharmaceuticals 50 Evamist TM 50 AMITIZA ® 50 Opana R 50 SEASONIQUE R 50 Astepro 50 EGRIFTA TM 50 Fortesta 50 ecallantide 50 mg capsules 50 Desloratadine 50 HIV integrase inhibitor 50 dosage strengths 50 #mg tablets [001] 50 Aldara ® 50 Eurand 50 Akorn Inc 50 Zingo TM 50 NVA# 50 Oracea ® 50 Biosimilar 50 Symbyax 50 Colazal 50 DRHP 50 Metformin HCl 50 DRAXIMAGE 50 PrevOnco 50 Ruconest 50 CUBICIN 50 MediGene 50 DepoDur 50 Polymer Microspheres 50 Ohm Laboratories 50 XAGRID 50 FACTIVE 50 Sumatriptan 50 pancrelipase 50 Supplemental Biologics License Application 50 nonsedating antihistamine 50 daily tramadol 50 Rhucin R 50 ratiopharm 50 Noven Therapeutics 50 Actavis Elizabeth 50 MEZAVANT 50 Isoptin 50 NUEDEXTA ™ 50 Daliresp 50 PENTASA 50 Clinigene 50 Zegerid 50 APF# 50 Teveten 50 Wellbutrin XL ® 50 Extavia 50 Sun Pharma 50 Active Pharmaceutical Ingredients 50 PANZYTRAT 50 Ampligen r 50 biosimilar versions 50 Omigard TM 50 Metoprolol Succinate 50 Oxytrol R 50 Carbatrol 50 Aphthasol R 50 Kapidex 50 biogenerics 50 Unichem 50 LOPROX R 50 Wyeth Effexor XR 50 fexofenadine 50 Ranexa R 50 sNDA submission 50 SURFAXIN 50 Dyloject TM 50 Urocidin 50 Actemra 50 entity NCE 50 patent litigations 50 Solzira 50 Qutenza 50 Pennsaid Plus 50 Ethypharm 50 bioequivalence 50 Allegra ® 50 Mucinex ® 50 Istalol 50 topical dermatology 50 Marketing Authorisation 50 ATPace 50 CARBATROL 50 ONTAK 50 indiplon 50 Fortigel 50 TachoSil 50 EpiCeram 50 Anturol 50 pexiganan 50 Sanctura 50 Generic Versions 50 Viviant 50 ProEthic 50 VPRIV 50 M Enoxaparin 50 rolling Biologics License 50 orphan designation 50 Omacor ® 50 FEMCON FE 50 submitted supplemental Biologics 50 Mometasone Furoate 50 acyclovir Lauriad ® 50 Approvable Letter 50 IV acetaminophen 50 VYVANSE 50 Glenmark Pharma 50 Generics 50 Cadila Healthcare Ltd 50 Grandix 50 Eraxis 50 sumatriptan DosePro 50 #mg dosage [001] 50 KADIAN ® 50 Ranbaxy Laboratories Ltd 50 Horizant 50 ECR Pharmaceuticals 49 Sanvar R 49 Market Approval PMA 49 Ultracet 49 rabeprazole 49 ADDERALL XR 49 Mutual Recognition Procedure 49 Actimmune R 49 Lipitor Plavix 49 Ind Swift 49 Synera 49 Phase III Clinical Trials 49 Luvox CR 49 Anchen 49 miconazole MBT 49 apaziquone 49 injectible 49 Osmotica 49 Stalevo ® 49 AzaSite Xtra 49 Azilect 49 Suven Life Sciences 49 patent expiries 49 Phase III clinical trials 49 Rectogesic 49 Zelrix 49 ABILIFY ® 49 dorzolamide 49 Opana ® 49 Bayer Schering 49 Urokinase 49 Amnesteem 49 Par Pharmaceutical 49 Dr Reddys 49 METOZOLV ODT 49 Sular ® 49 HFA MDI 49 VaxImmune 49 IND enabling 49 Captisol 49 Abstral ® 49 JB Chemicals 49 vinflunine 49 casopitant 49 Ipca Laboratories 49 Tekturna HCT 49 Certican 49 ESTRASORB 49 FineTech 49 outlicensed 49 Andrx generic 49 generic oral contraceptive 49 rhC1INH 49 Gland Pharma 49 OLUX 49 Files Investigational 49 Moxatag 49 Xenazine ® 49 WinRho SDF 49 Roche Chugai 49 oxycodone hydrochloride 49 ZALBIN 49 NSE SUNPHARMA 49 Niche Generics 49 NDDS 49 Hydrochloride 49 Clarithromycin 49 tafamidis 49 Kuvan 49 Amitiza 49 ONGLYZA ™ 49 CryoSeal 49 subsidiary Glenmark Generics 49 Aciphex R 49 Encysive 49 Polyphenon ® E 49 include Phenoptin TM 49 Qutenza TM 49 azelastine 49 bioequivalency 49 Targretin capsules 49 Cresp ® 49 Launches Generic Version 49 zolpidem tartrate sublingual tablet 49 tablets USP 49 Sucampo 49 Celgene Thalomid 49 ruxolitinib 49 ORENCIA R 49 ponatinib 49 Tekturna Rasilez 49 OFIRMEV 49 Perforomist 49 Evoltra R 49 rhThrombin 49 ophthalmic pharmaceutical 49 Orphan Drug Status 49 Ranexa 49 Xanodyne 49 Antegren 49 Intas Biopharmaceuticals 49 sublingual tablets 49 Release Capsules 49 STRIANT 49 formulations 49 bromfenac 49 Panzem R 49 Nippon Shinyaku 49 Risperidone Oral Solution 49 Citizen Petition 49 Aurobindo Pharma Ltd. 49 miconazole Lauriad ® 49 Aplenzin ™ 49 Treanda 49 Ketorolac 49 Captisol enabled 49 Ivax Pharmaceuticals 49 miconazole Lauriad R 49 Cladribine 49 JOULFERON 49 mg/#.# mg [003] 49 Premarket Approval PMA 49 Teikoku Pharma USA 49 Alkem Laboratories 49 Tilidine 49 PERLANE 49 Par Pharmaceuticals 49 Wockhardt 49 Navamedic 49 Akorn Strides LLC 49 oral mesalamine 49 Flutiform ™ 49 Decentralized Procedure 49 Vitaros R 49 HZT 49 highly purified pasteurized 49 Dabur Pharma 49 Clevudine 49 Submits NDA 49 Roxane Laboratories Inc. 49 Fast Track Status 49 proprietary transdermal patch 49 RELISTOR ® 49 Pravastatin 49 DepoDur TM 49 BLA resubmission 49 Fanapt TM 49 Firazyr 49 Requip XL 49 BioAlliance 49 Glenn Saldanha 49 Cimzia ® 49 desloratadine 49 JAK inhibitor 49 metformin HCl 49 Nexavar ® 49 Remoxy 49 Tyvaso 49 Cordarone 49 Feraheme ® 49 Aloxi ® 49 DCGI 49 Ferumoxytol 49 ZYFLO R 49 Rocephin 49 rosuvastatin calcium 49 Levetiracetam 49 BEMA Buprenorphine 49 Trelstar 49 ANDA submission 49 ANDA Filing 49 BioGlue ® 49 CLARINEX 49 fidaxomicin 49 Loramyc TM 49 Cardene 49 dexmethylphenidate hydrochloride 49 Restanza 49 RELISTOR 49 NitroMist 49 Esomeprazole 49 linaclotide 49 Ethyol 49 PDUFA 49 patent expirations 49 Oxaliplatin Injection 49 markets HP Acthar 49 ZEGERID Chewable Tablets 49 Centralized Procedure 49 pancreatic enzyme 49 prescription dermatological 49 Topiramate Tablets 49 anti infective ophthalmic 49 Master File DMF 49 Testosterone Gel 49 Cefepime 49 Flutiform 49 GLASSIA 49 HCl capsules 49 Firazyr ® 49 Bioniche Pharma 49 Octreolin 49 DORYX 49 ISO Vorin TM 49 balsalazide disodium Capsules 49 EndoTAG TM 49 PROCHIEVE ® 49 Namenda 49 SUPPRELIN LA 49 Acetavance TM 49 Imitrex 49 Ajanta Pharma 49 Cerepro ® 49 commercialize toremifene 49 Bharat Biotech 49 mg dosages 49 Teva Pharmaceuticals USA 49 SILENOR TM 49 Japanese Encephalitis vaccine 49 subsidiary Zydus Pharmaceuticals 49 Pfizer Zoloft 49 Sagent Pharmaceuticals 49 Citalopram 49 Methylin 49 Neurodex 49 OTC ZEGERID 49 Extended Release 49 BYETTA ® 49 Anturol TM 49 Atelvia 49 Bepreve 49 Humira adalimumab 49 MethyPatch 49 tablet formulation 49 NDA resubmission 49 fexofenadine hydrochloride 49 Fexofenadine 49 Infergen R 49 EpiPen Auto Injector 49 Estrostep 49 venlafaxine hydrochloride 49 Oral Solution 49 Dexilant 49 Bionutrics 49 Synerx 49 cefdinir 48 Novartis Galvus 48 COLAZAL ® 48 balsalazide disodium 48 RELOVAIR ™ 48 Naprelan R 48 Cilag 48 Caraco Pharma 48 Soliris TM eculizumab 48 EndoTAG TM -1 48 Roflumilast 48 Supernus 48 Fixed Dose Combination 48 Nimotuzumab 48 Marketing Authorizations 48 Fentanyl Taifun 48 Soriatane R 48 Transdel 48 ZEGERID OTC 48 Keppra XR 48 zafirlukast 48 pancreatic enzyme replacement 48 Levofloxacin 48 bicifadine 48 AcelRx 48 Impax generic 48 NDA BLA 48 Mitsubishi Tanabe 48 Saphris 48 Dabigatran etexilate 48 Genpharm 48 FOSAMAX PLUS D 48 #KSB 48 biobetter 48 ondansetron 48 Ganciclovir 48 Lilly Cymbalta 48 Kynapid 48 MOVIPREP R 48 hydrochloride tablets 48 mecamylamine hydrochloride 48 Approvable letter 48 tolperisone 48 Augment Injectable 48 APF# NDA 48 FDA Approval 48 License Application sBLA 48 sumatriptan succinate tablets 48 IV APAP 48 tramadol HCl 48 Simcor 48 Hectorol 48 Venlafaxine Hydrochloride