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(Click for frequent words.) 75 ANDAs 69 Abbreviated New 67 ANDA containing 65 Drug Application ANDA 63 Paragraph IV certification 62 Drug Application 62 Drug Applications ANDAs 61 ANDA filings 60 USFDA approval 60 ANDA applicant 60 ANDA filer 59 Paragraph IV 58 ANDAs abbreviated 58 USFDA 58 ANDA approvals 57 Para IV 57 Stavzor 56 Paragraph IV certifications 56 SEASONALE 56 ULTRASE 56 ANDA abbreviated 56 Biologics License Application 55 Orapred ODT 55 Amlodipine Besylate 55 Announces Tentative Approval 55 mg Tablets 55 Ondansetron 55 #mg #mg [002] 55 Paragraph IV Certification 55 Lupin Pharmaceuticals Inc. 54 Cefprozil 54 Metformin HCl 54 Barr ANDA 54 IND Investigational New 54 Femcon 54 SEASONALE R 54 Biological License Application 54 5mg #mg #mg 54 Oxytrol 54 Opana ER 54 ANDAs pending 54 Synthon 54 Synera 54 ZEGERID Capsules 54 Drug Submission 54 Altoprev 53 Marketing Authorisation Application 53 Doryx 53 Hatch Waxman exclusivity 53 Marketing Authorisation Application MAA 53 DMFs 53 SOLODYN R 53 Para IVs 53 TRELSTAR R 53 InvaGen 53 Keflex 53 Cefazolin 53 fluvoxamine maleate 53 Valganciclovir 53 Amlodipine Besylate Tablets 53 amlodipine besylate 53 Pennsaid 53 Benazepril 53 Zensana 53 Generic Version 53 Focalin XR R 53 Daytrana ® 53 Gynazole 1 53 Biologics License Application BLA 53 ANDAs pending approval 53 INDs 53 Trelstar R 53 Genpharm 53 pediatric exclusivity 53 New Drug Application 53 cycle oral contraceptive 52 metoprolol succinate 52 application sNDA 52 CIP TRAMADOL ER 52 Levocetirizine 52 Oracea 52 orally disintegrating tablets 52 Ofloxacin 52 Biologic License Application 52 Omeprazole 52 sBLA 52 silodosin 52 FDA Approval 52 Ultracet R 52 Pennsaid Plus 52 Lamictal ODT 52 Enjuvia 52 ANDA submission 52 Applications ANDA 52 Release Tablets 52 Sumatriptan Succinate Tablets 52 sNDA 52 Ciclesonide 52 Nascobal 52 Orally Disintegrating Tablets 52 Mylan Receives Approval 52 Amneal 52 Cefdinir 52 ADDERALL XR R 52 ANDA Abbreviated New 52 Pennsaid R 52 enoxaparin sodium injection 52 ONSOLIS 52 Oxytrol R 52 balsalazide disodium 52 Bupropion HCl ER 52 Teva ANDA 52 FDA Approvable Letter 52 Chemical Entity NCE 52 Hatch Waxman Act 52 VISICOL R 52 Desloratadine 52 Onsolis 52 OLEPTRO ™ 52 T Pred 52 Extended Release 52 Hatch Waxman Amendments 51 Zenpep 51 Gestiva TM 51 CRINONE ® 51 Focalin XR ® 51 BioAlliance 51 Drug Administration USFDA 51 VALSTAR 51 orally disintegrating 51 BRILINTA 51 generic Copaxone 51 Velac 51 Application BLA 51 Biologic License Application BLA 51 Levofloxacin 51 Glumetza 51 Hydrochloride 51 MONOVISC 51 Flutiform TM 51 Oral Suspension 51 Frova ® 51 #mg dosage strengths 51 Intellipharmaceutics 51 Risperidone Oral Solution 51 SOLODYN 51 RAPAFLO 51 Zolpimist 51 Ondansetron Injection 51 LOPROX R 51 tablets USP 51 Fortical R 51 balsalazide 51 Premarket Approval Application 51 Extended Release Tablets 51 Testosterone Gel 51 pantoprazole sodium 51 Gabapentin Capsules 51 NitroMist TM 51 Oral Solution 51 Divalproex Sodium 51 Lotrel ® 51 Sanctura XR 51 APF# 51 Ciclopirox 51 RESTYLANE R 51 Cellegesic 51 Anchen 51 Vitaros 51 Suprax 51 Rapaflo 51 Wellbutrin XL R 51 Abstral 51 TRELSTAR ® 51 Pliaglis 51 Ampligen r 51 BEMA Fentanyl 51 Upsher Smith 51 hydrochloride tablets 51 Roxane Laboratories Inc. 51 SEASONIQUE 51 Generic Version Of 51 invalid unenforceable 51 tablet formulation 51 Zidovudine Tablets 50 ondansetron 50 Solodyn 50 Terbinafine 50 Tamsulosin 50 NDA submission 50 ethinyl estradiol tablets 50 Inhalation Aerosol 50 DORIBAX 50 Keppra ® XR 50 Emezine 50 Velaglucerase Alfa 50 Tekturna HCT 50 Marketing Authorization Application 50 Exocrine Pancreatic Insufficiency 50 EGRIFTA TM 50 Abstral ® 50 HFA MDI 50 Xyzal R 50 Active Pharmaceutical Ingredient 50 Evamist TM 50 Sumatriptan Succinate 50 Levoleucovorin 50 Sotret 50 losartan potassium 50 generic injectable 50 SFDA approval 50 Oral Suspension #mg 50 Maleate 50 Linjeta TM 50 Ceftriaxone 50 morphine sulfate extended 50 Complete Response 50 5 HT3 antagonist 50 OLEPTRO 50 gets USFDA nod 50 NitroMist 50 Clindesse TM 50 GRALISE 50 Oracea TM 50 FDA approvable letter 50 Glenmark 50 USFDA nod 50 udenafil 50 Oracea ® 50 faropenem 50 PROTONIX 50 FEMCON FE 50 AstraZeneca Toprol XL 50 Kyowa Kirin 50 Cefprozil tablets 50 ZANAFLEX 50 #mg tablets [001] 50 sumatriptan injection 50 ABILIFY R 50 REPLAGAL 50 INTUNIV TM 50 Dyloject TM 50 Factive 50 Lidoderm ® 50 Interpharm 50 topical NSAID 50 Tostrex 50 Apricus Bio 49 HCl tablets 49 Ranbaxy 49 naproxen esomeprazole magnesium 49 Argatroban 49 approvable letters 49 Nasacort 49 Akorn 49 1mg 2mg 49 Preotact 49 Barr Laboratories Inc. 49 ATPace 49 NEBIDO 49 oxycodone hydrochloride 49 Codeine Phosphate 49 Zosyn 49 Aldara ® 49 Strativa 49 supplemental biologics 49 Fortamet 49 Abacavir Sulfate 49 Exalgo 49 Mylan Pharmaceuticals Inc. 49 Amrix 49 Morphine Sulfate 49 Loramyc ® 49 Paragraph IV Notice 49 GRAS notification 49 AMRIX 49 FDA Accepts 49 Cetirizine 49 cyclobenzaprine hydrochloride extended 49 Andrx generic 49 lorcaserin NDA 49 Solzira TM 49 LUVOX CR 49 Aplenzin ™ 49 Focalin XR 49 k Premarket Notification 49 fentanyl transdermal system 49 EtherProbe 49 Aurobindo Pharma 49 ER Tablets 49 Lannett 49 BYETTA ® 49 dorzolamide 49 Levetiracetam Tablets 49 Oxybutynin 49 OSMOPREP 49 mg capsules 49 anti emetic 49 PLIVA 49 Dexilant 49 Approvable Letter 49 Sancuso 49 Comtan 49 TACLONEX 49 Opana R 49 sublingual tablets 49 balsalazide tablet 49 nasal calcitonin product 49 TRELSTAR 49 RYZOLT 49 ADDERALL XR 49 sumatriptan succinate injection 49 Synerx Pharma 49 Vitaros R 49 Zebinix R 49 pancrelipase 49 SPD# 49 FACTIVE R gemifloxacin 49 Fexofenadine 49 Metoprolol Succinate 49 Taclonex 49 Teva Pharmaceuticals USA 49 Strides Arcolab 49 Razadyne ER 49 Orathecin 49 Zydus Cadila 49 Biaxin XL 49 Zingo TM 49 Marketing Authorization Application MAA 49 PDUFA Date 49 AstraZeneca Toprol 49 SYCREST 49 Lupin Pharmaceuticals 49 Fortovase 49 Par Pharma 49 Par Pharmaceuticals 49 esomeprazole magnesium 49 VIVITROL ® 49 Somatuline R Autogel R 49 Caraco 49 ANDA Filing 49 Metformin Hydrochloride 49 oral contraceptives Loestrin 49 ISENTRESS raltegravir 49 Mirtazapine 49 #mg #mg #mg [001] 49 Andrx 49 Chewable Tablets 49 SEASONIQUE TM 49 Lupin Ltd 49 Tramadol ER 49 Glenmark Generics 49 indiplon capsules 49 Fixed Dose Combination 49 Hydromorphone 49 Clarithromycin 49 Ranexa R 49 Citizen Petition 49 Akorn Strides 49 Indiplon 49 Venlafaxine Hydrochloride 49 antiemetic 48 markets HP Acthar 48 Valacyclovir 48 Stalevo ® 48 Ciprofloxacin 48 Formoterol 48 dalbavancin 48 ATRIPLA TM 48 Uracyst ® 48 Oxycodone Hydrochloride 48 granulated mesalamine 48 Seasonique 48 Glucotrol XL 48 Priority Review 48 Cenestin 48 paliperidone palmitate 48 Keppra XR 48 generic Lipitor 48 Lovaza TM 48 Zanaflex 48 TRANSDUR Sufentanil 48 entity NCE 48 Release Capsules 48 COLAZAL ® 48 Simvastatin Tablets 48 Civacir 48 Methylin 48 Loestrin 48 Receives Tentative Approval 48 Horizant ™ 48 Act PDUFA date 48 Cobalt Pharmaceuticals 48 Topical Gel 48 BENLYSTA 48 CIP Fenofibrate 48 Requip XL 48 telavancin NDA 48 SEASONIQUE R 48 Exelbine 48 ulipristal acetate 48 Andrx Pharmaceuticals 48 pramipexole dihydrochloride 48 Betaseron ® 48 mg dosage 48 Polyphenon ® E 48 Risperidone 48 EGRIFTA ™ 48 Dalbavancin 48 ABILIFY ® 48 Generic Versions 48 HCl capsules 48 SILENOR 48 Oxandrin R 48 Glumetza TM 48 ANDAs pending FDA 48 inhalation aerosol 48 ALGRX 48 Zanaflex Capsules 48 Specifar 48 Fenoglide 48 NovaDel 48 Orphan Drug designations 48 ASACOL 48 Sular formulation 48 Entocort 48 alogliptin 48 Duramed 48 Surfaxin lucinactant 48 Orexo 48 Allegra ® 48 Esomeprazole 48 Uracyst 48 Stedesa 48 Xyzal 48 Perforomist 48 Drug Applications NDAs 48 Loramyc 48 Stalevo 48 topical gel 48 injectable formulations 48 ProQuin XR 48 Captisol enabled 48 Urokinase 48 tramadol ER 48 Duramed Pharmaceuticals Inc. 48 Ticagrelor 48 sNDAs 48 AzaSite Plus 48 BioDelivery Sciences 48 Nascobal R 48 Launches Generic Version 48 Teveten 48 RELISTOR ® 48 OLEPTRO TM 48 Onco TCS 48 formoterol fumarate 48 Pentasa 48 Carbidopa Levodopa 48 BLAs 48 Soriatane 48 Glucophage R 48 PDUFA date 48 ONSOLIS TM 48 HepaGam B 48 Marketing Authorization Applications 48 BioDelivery 48 OFIRMEV 48 venlafaxine hydrochloride 48 OPANA ER 48 Angelini Labopharm 48 supplemental Biologics License Application 48 Anidulafungin 48 Megace ES 48 abacavir sulfate lamivudine 48 CUBICIN 48 Alvesco R 48 Emezine R 48 LIALDA 48 Periostat 48 Losartan Potassium 48 include Phenoptin TM 48 Receives Tentative FDA 48 Daytrana TM 48 Investigational 48 Lidoderm R 48 Filgrastim 48 Advancis 48 CorePharma LLC 48 cephalosporin 48 submitted supplemental Biologics 48 Ketorolac 48 miconazole Lauriad ® 48 Tablets USP 48 adenosine injection 48 amlodipine benazepril 48 dronabinol 48 Adcirca 48 Trelstar 47 ALVESCO R 47 EpiCept NP 1 47 Nitrofurantoin 47 Anturol TM 47 capsules USP 47 Caduet 47 tacrolimus capsules 47 biosimilar 47 TachoSil 47 Cerepro ® 47 Amphastar 47 Vinita Gupta 47 TRANSDUR Bupivacaine 47 ETHEX 47 UCB Keppra 47 Oxcarbazepine 47 Oxaliplatin Injection 47 Fanapt ™ 47 proprietary transdermal patch 47 FIRAZYR 47 Delayed Release 47 GlaxoSmithKline Imitrex 47 Lamivudine 47 Daytrana ™ 47 GLASSIA 47 Ropinirole 47 #mg tablet [001] 47 Ixempra 47 Indaflex 47 Cephalexin 47 ATD gel 47 dosage forms 47 Biologics Licensing 47 Omnicef 47 Lipofen 47 FUSILEV ® 47 injection USP 47 Famvir ® 47 MK #B 47 Fexofenadine Hydrochloride 47 PROCHIEVE ® 47 Mylan ANDA 47 Fortigel 47 anagrelide hydrochloride 47 COLAZAL R 47 SILENOR ™ 47 EMBEDA ™ 47 Omnitrope 47 oxymorphone ER 47 NRP# 47 Hatch Waxman litigation 47 ELADUR 47 Felodipine 47 XAGRID 47 zolpidem tartrate 47 Loramyc ™ 47 bioequivalent 47 Fentanyl TAIFUN R 47 #mg #mg #mg #mg [002] 47 Pexeva 47 Mometasone Furoate 47 diclofenac sodium 47 Celgene Thalomid 47 prednisolone sodium phosphate 47 Luvox CR 47 Octreotide 47 Rasagiline 47 Roxane Laboratories 47 Loramyc R 47 mg tablets 47 Periostat R 47 NEBIDO R 47 tizanidine hydrochloride 47 Colesevelam 47 Ethinyl Estradiol 47 donepezil hydrochloride 47 SANCTURA XR 47 Marketing Authorization 47 Zegerid 47 METOZOLV ODT 47 Impax generic 47 mesylate 47 #mg #mg [003] 47 mg/#.# mg [003] 47 faropenem medoxomil 47 Frova R 47 Dyloject 47 zolpidem tartrate sublingual tablet 47 balsalazide disodium Capsules 47 Ortho Cept 47 Indomethacin 47 Ferrlecit R 47 miconazole MBT 47 SCOLR 47 Provisional Patent 47 Fosphenytoin 47 Fast Track Status 47 PhosLo 47 Daewoong 47 Pruvel 47 therefore therapeutically equivalent 47 GELNIQUE 47 Zidovudine 47 estradiol transdermal spray 47 lamivudine zidovudine 47 MethyPatch 47 BEMA Granisetron 47 sodium phosphate dibasic anhydrous 47 Cefepime 47 PMA submission 47 Testim 47 experimental immunotherapeutics antivirals AmpligeGI mucosa resulting 47 Teflaro 47 EpiCeram 47 DepoDur 47 Ipratropium Bromide 47 Cobrek 47 Luveniq 47 Zuplenz 47 Ranitidine 47 Expedited Review 47 Generic Protonix 47 Sabex Holdings Ltd. 47 Pennsaid ® 47 HP Acthar R 47 Veregen R 47 Global Generics 47 WHO prequalification 47 gabapentin capsules 47 Proquin XR 47 XIBROM 47 ScinoPharm 47 albuterol sulfate 47 budesonide inhalation suspension 47 granisetron formulated 47 PENTASA 47 vinflunine 47 pending ANDAs 47 rabeprazole 47 Alphapharm 47 Oscient 47 BLA filing 47 Omigard TM 47 betamethasone dipropionate 47 Istalol 47 8mg 47 HYZAAR 47 octreotide acetate 47 Fanapt TM 47 Cetirizine Hydrochloride 47 INKP 47 overactive bladder AA# 47 trazodone hydrochloride 47 Wellbutrin XL ® 47 M Enoxaparin 47 IV APAP 47 BYDUREON 47 Extended Release Capsules 47 Teva Pharma 47 RAZADYNE 47 Besivance 47 Diclofenac Sodium 47 ACTIQ 47 oxybutynin 47 tramadol HCl 47 Taclonex R 47 PULMICORT 47 Quinapril 47 THALOMID 47 Drug Submission NDS 47 Immune Globulin Human 47 Citalopram 47 Zelrix 47 METOZOLV ™ 47 Fortical 47 outlicensed 47 Aplenzin TM 47 EvaMist TM 47 orphan designation 47 guaifenesin 47 PDE4 inhibitor 47 PULSYS 47 SCHWARZ PHARMA 47 Topiramate tablets 47 BEMA ™ 47 Oracea R 47 Oxandrin 47 Teva Provides Update 46 Junovan 46 successfully commercialize Iluvien 46 Orphan Drug Status 46 Zegerid OTC 46 sterile injectable 46 mometasone furoate 46 Duramed Pharmaceuticals 46 EXALGO 46 Suprax R 46 Xolegel 46 Tindamax 46 Mycophenolate Mofetil 46 gabapentin tablets 46 Eurand 46 Qutenza 46 Pravastatin 46 dexmethylphenidate hydrochloride 46 ciprofloxacin hydrochloride 46 Actavis Elizabeth 46 Vitaros ® 46 EtherTone 46 Icatibant 46 Teikoku Pharma USA 46 octreotide implant 46 Orphan Designation 46 sevelamer carbonate 46 Relistor 46 Zonisamide 46 HCl Injection 46 JBCPL 46 EDQM 46 monobasic monohydrate USP 46 XYREM 46 Ditropan XL 46 EMSAM 46 Ultram ER 46 Transdermal System 46 Mutual Recognition Procedure 46 Marketing Authorisation 46 PRISTIQ 46 Metronidazole 46 Cutivate 46 NexACT ® 46 Somatuline Autogel 46 Akorn Strides LLC 46 Aloxi Injection 46 oxybutynin chloride 46 Sanvar R 46 ONGLYZA ™ 46 Sumatriptan 46 capsule formulation 46 nonsedating antihistamine 46 Zyflo CR 46 Exalgo TM 46 Soriatane R 46 Cardene R 46 Piperacillin 46 PROVIGIL R 46 Polymer Microspheres 46 GLUMETZA 46 crofelemer 46 Tenofovir Disoproxil Fumarate 46 Silenor ® doxepin 46 DYNACIN R Tablets 46 Propoxyphene 46 NUEDEXTA ™ 46 Anti TNF 46 Extina 46 Hydrapol TM 46 NeutroPhase 46 DuoNeb 46 Premarket Approval PMA 46 biogeneric 46 Crofelemer 46 Solzira 46 Ondansetron Injection USP 46 SUMAVEL DosePro 46 Ohm Laboratories 46 Ketotransdel 46 JANUVIA 46 Replagal 46 Orphan Drug Designation 46 IBPL 46 IV acetaminophen 46 Zalbin 46 BEMA TM Fentanyl 46 Captisol 46 progesterone gel 46 hydrochloride extended 46 ALZA 46 Cetirizine Hydrochloride Syrup 46 Loxapine 46 Injection USP 46 Ethypharm 46 #mg Tablets [001] 46 Pulsys 46 Nebido 46 VYVANSE 46 Tilidine 46 HYLENEX 46 Xenazine ® 46 Fortesta 46 topical ophthalmic 46 RECOTHROM R 46 k premarket 46 DepoDur TM 46 topical non steroidal 46 THROMBIN JMI ® 46 Emend 46 sufentanil 46 Oral BDP 46 Elestrin 46 rosuvastatin calcium 46 Sublinox 46 Rectogesic 46 XiDay 46 Novartis Galvus 46 Application MAA 46 generation cephalosporin 46 Pilocarpine 46 Benazepril Hydrochloride 46 Topotecan 46 Teva 46 R vancomycin hydrochloride 46 Unifill 46 Tazobactam 46 Anturol 46 Lipitor atorvastatin calcium 46 Tablets #mg [001] 46 Agenerase 46 Orapred R 46 BDSI 46 #mg dosage [001] 46 PDUFA Prescription Drug 46 REMOXY 46 Metoprolol Succinate Extended Release 46 Noven 46 Safe GRAS status 46 Clevudine 46 mg dosages 46 GP Pharm 46 DRAXIMAGE 46 ZEGERID R 46 Taclonex Scalp R 46 Galantamine 46 Flutiform ™ 46 Intas 46 transmucosal 46 Fast Track designations 46 Gabapentin 46 Catapres TTS 46 IVAX 46 metformin HCl 46 Zyflo 46 severe hypercholesterolemia 46 Natco Pharma 46 Acurox 46 Fesoterodine 46 Topiramate Tablets 46 tolperisone 46 Bioxel 46 clopidogrel bisulfate 46 Tablets sodium phosphate 46 DAYTRANA TM 46 #mg dosage strength 46 Sanvar 46 Efudex 46 taliglucerase alfa 46 Combunox 46 markets COLAZAL 46 PREOS 46 Elevess 46 ZEGERID Powder 46 Feraheme ® 46 Source Photonics 46 KRYSTEXXA 46 oxandrolone USP 46 Zydus 46 bioequivalence 46 mesylate tablets 46 Uracyst R 46 methylnaltrexone bromide 46 Paragraph IV patent 46 Alvogen 46 Elagolix 46 Delayed Release Tablets 46 topical gel formulation 46 Indaflex TM 46 azelastine 46 Doxycycline Tablets 46 Eloxatin ® 46 Hydrochloride tablets 46 Roflumilast 46 Tiazac 46 SUPPRELIN LA 46 AstraZeneca Symbicort 46 CHMP recommendation 46 Ustekinumab 46 Ursodiol 46 Eligard R 46 transdermal patch 46 Moxatag 46 Oravig ® 46 Sanctura 46 Renvela ® 46 IntelliPharmaCeutics 46 Akela Pharma 46 ONTAK 46 pancreatic enzyme 46 Zindaclin R 46 highly purified pasteurized 46 generic Protonix 46 SEASONIQUE ® 46 mg Extended Release 46 BiDil XR 46 ZALBIN 46 Carbatrol 46 Aphthasol R 46 PrevOnco 46 Rotarix R 46 Paxil CR TM 46 Capsules USP 46 bioequivalency 46 Patent Application 46 NDDS 46 Sitagliptin 46 Zelapar 46 STRIANT 46 Indoco 46 ofloxacin 46 GRAS status 46 PerClot 46 Ipca 46 FOSAMAX PLUS D 46 #mg Tablets [002] 46 ZEGERID Chewable Tablets 46 TELINTRA 46 Aloxi ® 46 CIP ISOTRETINOIN 46 Fenofibrate 46 OMNARIS Nasal Spray 46 NanoCrystal technology 46 generic Allegra 46 rabeprazole sodium 46 Naprelan R 46 TRISENOX ® 45 FDA 45 risedronate sodium 45 CDP# 45 mg/#.# mg [002] 45 Lidoderm 45 OMNARIS 45 Glucophage XR 45 Brovana 45 trospium chloride 45 Vfend 45 APF# NDA 45 prGCD 45 tiapamil 45 Confirms Patent 45 Retacrit 45 PreHistin TM 45 Renvela 45 NeoVisc 45 Medoxomil 45 Market Approval PMA 45 Natroba 45 anti infective 45 fexofenadine hydrochloride 45 Oral Spray 45 Nutra Pharma wholly owned 45 Lauriad ® 45 Approvable letter 45 Oral Suspension USP 45 Durezol TM 45 anti infective ophthalmic 45 buccal tablet 45 ratiopharm 45 Supplemental Biologics License Application 45 Asacol 45 sumatriptan succinate 45 Files Investigational 45 Submits Supplemental 45 Iluvien ® 45 Adoxa 45 TRISENOX R 45 Ganciclovir 45 Doryx ® 45 Azilect ® 45 KRYSTEXXA TM 45 Voraxaze 45 Darunavir 45 DPP4 inhibitor 45 Itraconazole 45 Decentralized Procedure 45 iloprost Inhalation Solution 45 intravenous acetaminophen 45 VITAGEL 45 generic Valtrex 45 oxycodone HCl 45 Cresp ® 45 #mg tablets [002] 45 ETHEX Corporation 45 LibiGel ® 45 Sporanox 45 Tablets #mg [002] 45 Spiegelmer ® 45 SOLODYN ® 45 Amnesteem 45 Kaletra tablet 45 Cephalosporin 45 Centralized Procedure