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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 2013

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/01/2013 UVADEX
NDA #020969		 SUPPL-6 METHOXSALEN THERAKOS DEVELOPMENT Labeling Approval
11/01/2013 EVOXAC
NDA #020989		 SUPPL-12 CEVIMELINE HYDROCHLORIDE COSETTE Manufacturing (CMC) Approval
11/01/2013 EXJADE
NDA #021882		 SUPPL-18 DEFERASIROX NOVARTIS Manufacturing (CMC) Approval
11/01/2013 EMBEDA
NDA #022321		 SUPPL-13 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Manufacturing (CMC) Approval
11/01/2013 LATISSE
NDA #022369		 SUPPL-9 BIMATOPROST ABBVIE Manufacturing (CMC) Approval
11/01/2013 CITALOPRAM HYDROBROMIDE
ANDA #077629		 SUPPL-7 CITALOPRAM HYDROBROMIDE CHARTWELL MOLECULAR Labeling Approval
11/01/2013 CITALOPRAM HYDROBROMIDE
ANDA #077629		 SUPPL-8 CITALOPRAM HYDROBROMIDE CHARTWELL MOLECULAR Labeling Approval
11/01/2013 GAZYVA
BLA #125486		 ORIG-1 OBINUTUZUMAB GENENTECH Approval
11/04/2013 FURADANTIN
NDA #009175		 SUPPL-36 NITROFURANTOIN CASPER PHARMA LLC Labeling Approval
11/04/2013 MINIPRESS
NDA #017442		 SUPPL-41 PRAZOSIN HYDROCHLORIDE PFIZER Labeling Approval
11/04/2013 ALTACE
NDA #019901		 SUPPL-62 RAMIPRIL KING PHARMS LLC Labeling Approval
11/04/2013 REVLIMID
NDA #021880		 SUPPL-38 LENALIDOMIDE BRISTOL MYERS SQUIBB Labeling Approval
11/04/2013 TEKTURNA
NDA #021985		 SUPPL-25 ALISKIREN HEMIFUMARATE LXO IRELAND Labeling Approval
11/04/2013 TEKTURNA HCT
NDA #022107		 SUPPL-23 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE NODEN PHARMA Labeling Approval
11/04/2013 TEKAMLO
NDA #022545		 SUPPL-14 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE NOVARTIS Labeling Approval
11/04/2013 AMTURNIDE
NDA #200045		 SUPPL-14 ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE NOVARTIS Labeling Approval
11/04/2013 DOCETAXEL
NDA #203551		 SUPPL-1 DOCETAXEL ACTAVIS Labeling Approval
11/05/2013 PAREMYD
NDA #019261		 SUPPL-13 HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
11/05/2013 ZESTRIL
NDA #019777		 SUPPL-63 LISINOPRIL TWI PHARMS Labeling Approval
11/05/2013 ZESTORETIC
NDA #019888		 SUPPL-55 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
11/05/2013 FINASTERIDE
ANDA #076905		 ORIG-1 FINASTERIDE TEVA Approval
11/05/2013 FINASTERIDE
ANDA #078161		 ORIG-1 FINASTERIDE NATCO PHARMA Approval
11/05/2013 FINASTERIDE
ANDA #078371		 ORIG-1 FINASTERIDE ACTAVIS TOTOWA Approval
11/05/2013 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091375		 SUPPL-4 LEVOFLOXACIN HIKMA FARMACEUTICA Labeling Approval
11/05/2013 PARICALCITOL
ANDA #091583		 ORIG-1 PARICALCITOL TEVA PHARMS USA Tentative Approval
11/05/2013 FINASTERIDE
ANDA #091643		 ORIG-1 FINASTERIDE ACCORD HLTHCARE Approval
11/05/2013 LEVOFLOXACIN
ANDA #202328		 SUPPL-3 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
11/05/2013 FINASTERIDE
ANDA #203687		 ORIG-1 FINASTERIDE AUROBINDO PHARMA LTD Approval
11/05/2013 BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203895		 ORIG-1 BUPIVACAINE HYDROCHLORIDE EUGIA PHARMA Approval
11/06/2013 ARALEN
NDA #006002		 SUPPL-43 CHLOROQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
11/06/2013 ARALEN HYDROCHLORIDE
NDA #006002		 SUPPL-43 CHLOROQUINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
11/06/2013 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-106 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/06/2013 CARDURA
NDA #019668		 SUPPL-26 DOXAZOSIN MESYLATE VIATRIS Labeling Approval
11/06/2013 REPRONEX
BLA #021047		 SUPPL-13 MENOTROPINS (FSH;LH) FERRING Approval
11/06/2013 RAPAMUNE
NDA #021110		 SUPPL-69 SIROLIMUS PF PRISM CV Manufacturing (CMC) Approval
11/06/2013 AFINITOR
NDA #022334		 SUPPL-22 EVEROLIMUS NOVARTIS Efficacy Approval
11/06/2013 PREVPAC (COPACKAGED)
NDA #050757		 SUPPL-17 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
11/06/2013 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078385		 SUPPL-10 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
11/06/2013 REMICADE
BLA #103772		 SUPPL-5359 INFLIXIMAB CENTOCOR INC Approval
11/06/2013 DOCETAXEL
NDA #201195		 SUPPL-5 DOCETAXEL ACCORD HLTHCARE Manufacturing (CMC) Approval
11/06/2013 MYTESI
NDA #202292		 SUPPL-1 CROFELEMER NAPO PHARMS INC Manufacturing (CMC) Approval
11/06/2013 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202771		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
11/06/2013 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #202870		 ORIG-1 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE ALEMBIC Approval
11/06/2013 AFINITOR DISPERZ
NDA #203985		 SUPPL-3 EVEROLIMUS NOVARTIS PHARM Efficacy Approval
11/07/2013 HUMULIN N
BLA #018781		 SUPPL-118 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 HUMULIN N
BLA #018781		 SUPPL-122 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 HUMULIN 70/30
BLA #019717		 SUPPL-98 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 HUMULIN 70/30
BLA #019717		 SUPPL-101 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-98 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-101 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/07/2013 MAGNESIUM SULFATE IN PLASTIC CONTAINER
NDA #020309		 SUPPL-20 MAGNESIUM SULFATE HOSPIRA Manufacturing (CMC) Approval
11/07/2013 ZANAFLEX
NDA #020397		 SUPPL-26 TIZANIDINE HYDROCHLORIDE LEGACY Labeling Approval
11/07/2013 NORVIR
NDA #020659		 SUPPL-58 RITONAVIR ABBVIE Labeling Approval
11/07/2013 ACTIQ
NDA #020747		 SUPPL-37 FENTANYL CITRATE CEPHALON REMS Approval
11/07/2013 NORVIR
NDA #020945		 SUPPL-36 RITONAVIR ABBVIE Labeling Approval
11/07/2013 RELPAX
NDA #021016		 SUPPL-25 ELETRIPTAN HYDROBROMIDE UPJOHN Manufacturing (CMC) Approval
11/07/2013 KALETRA
NDA #021226		 SUPPL-38 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/07/2013 KALETRA
NDA #021251		 SUPPL-46 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/07/2013 ZANAFLEX
NDA #021447		 SUPPL-11 TIZANIDINE HYDROCHLORIDE LEGACY Labeling Approval
11/07/2013 CADUET
NDA #021540		 SUPPL-30 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
11/07/2013 CADUET
NDA #021540		 SUPPL-31 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
11/07/2013 PLIAGLIS
NDA #021717		 SUPPL-5 LIDOCAINE; TETRACAINE CRESCITA THERAP Labeling Approval
11/07/2013 FOSAMAX PLUS D
NDA #021762		 SUPPL-18 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
11/07/2013 KALETRA
NDA #021906		 SUPPL-39 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/07/2013 FENTORA
NDA #021947		 SUPPL-17 FENTANYL CITRATE CEPHALON REMS Approval
11/07/2013 PREZISTA
NDA #021976		 SUPPL-33 DARUNAVIR JANSSEN PRODS Labeling Approval
11/07/2013 XYZAL
NDA #022064		 SUPPL-28 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Labeling Approval
11/07/2013 XYZAL
NDA #022157		 SUPPL-12 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Labeling Approval
11/07/2013 TACLONEX
NDA #022185		 SUPPL-15 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
11/07/2013 TACLONEX
NDA #022185		 SUPPL-16 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
11/07/2013 TACLONEX
NDA #022185		 SUPPL-15 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
11/07/2013 TACLONEX
NDA #022185		 SUPPL-16 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Labeling Approval
11/07/2013 ONSOLIS
NDA #022266		 SUPPL-12 FENTANYL CITRATE ADALVO REMS Approval
11/07/2013 NORVIR
NDA #022417		 SUPPL-10 RITONAVIR ABBVIE Labeling Approval
11/07/2013 ABSTRAL
NDA #022510		 SUPPL-7 FENTANYL CITRATE SENTYNL THERAPS INC REMS Approval
11/07/2013 LAZANDA
NDA #022569		 SUPPL-12 FENTANYL CITRATE BTCP PHARMA Manufacturing (CMC) Approval
11/07/2013 LAZANDA
NDA #022569		 SUPPL-15 FENTANYL CITRATE BTCP PHARMA REMS Approval
11/07/2013 LAZANDA
NDA #022569		 SUPPL-17 FENTANYL CITRATE BTCP PHARMA REMS Approval
11/07/2013 FENTANYL CITRATE
ANDA #077312		 SUPPL-5 FENTANYL CITRATE PAR PHARM REMS Approval
11/07/2013 RISPERIDONE
ANDA #078528		 SUPPL-4 RISPERIDONE SANDOZ Labeling Approval
11/07/2013 FENTANYL CITRATE
ANDA #078907		 SUPPL-11 FENTANYL CITRATE SPECGX LLC REMS Approval
11/07/2013 OLANZAPINE
ANDA #200221		 SUPPL-1 OLANZAPINE JUBILANT GENERICS Labeling Approval
11/07/2013 DONEPEZIL HYDROCHLORIDE
ANDA #201146		 SUPPL-2 DONEPEZIL HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
11/07/2013 JAKAFI
NDA #202192		 SUPPL-4 RUXOLITINIB PHOSPHATE INCYTE CORP Manufacturing (CMC) Approval
11/07/2013 SUBSYS
NDA #202788		 SUPPL-10 FENTANYL BTCP PHARMA REMS Approval
11/07/2013 PREZISTA
NDA #202895		 SUPPL-10 DARUNAVIR JANSSEN PRODS Labeling Approval
11/08/2013 SOLU-CORTEF
NDA #009866		 SUPPL-96 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
11/08/2013 THAM
NDA #013025		 SUPPL-55 TROMETHAMINE HOSPIRA Manufacturing (CMC) Approval
11/08/2013 THAM-E
NDA #013025		 SUPPL-55 POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE HOSPIRA Manufacturing (CMC) Approval
11/08/2013 TEGRETOL
NDA #016608		 SUPPL-108 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
11/08/2013 FREAMINE 8.5%
NDA #016822		 SUPPL-81 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE HBC 6.9%
NDA #016822		 SUPPL-81 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE II 8.5%
NDA #016822		 SUPPL-81 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE III 10%
NDA #016822		 SUPPL-81 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE III 3% W/ ELECTROLYTES
NDA #016822		 SUPPL-81 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE III 8.5%
NDA #016822		 SUPPL-81 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 FREAMINE III 8.5% W/ ELECTROLYTES
NDA #016822		 SUPPL-81 AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE B BRAUN Manufacturing (CMC) Approval
11/08/2013 DEMSER
NDA #017871		 SUPPL-18 METYROSINE BAUSCH Manufacturing (CMC) Approval
11/08/2013 TEGRETOL
NDA #018281		 SUPPL-56 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
11/08/2013 TEGRETOL
NDA #018927		 SUPPL-49 CARBAMAZEPINE NOVARTIS Manufacturing (CMC) Approval
11/08/2013 TROPHAMINE
NDA #019018		 SUPPL-31 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 TROPHAMINE 10%
NDA #019018		 SUPPL-31 AMINO ACIDS B BRAUN Manufacturing (CMC) Approval
11/08/2013 INDIUM IN 111 OXYQUINOLINE
NDA #019044		 SUPPL-22 INDIUM IN-111 OXYQUINOLINE GE HEALTHCARE Manufacturing (CMC) Approval
11/08/2013 EPI E Z PEN JR
NDA #019430		 SUPPL-56 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
11/08/2013 EPIPEN
NDA #019430		 SUPPL-56 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
11/08/2013 EPIPEN E Z PEN
NDA #019430		 SUPPL-56 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
11/08/2013 EPIPEN JR.
NDA #019430		 SUPPL-56 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
11/08/2013 LUPRON DEPOT
NDA #020517		 SUPPL-34 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Manufacturing (CMC) Approval
11/08/2013 MINIRIN
NDA #021333		 SUPPL-7 DESMOPRESSIN ACETATE FERRING Labeling Approval
11/08/2013 EMTRIVA
NDA #021500		 SUPPL-24 EMTRICITABINE GILEAD Manufacturing (CMC) Approval
11/08/2013 TRUVADA
NDA #021752		 SUPPL-40 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
11/08/2013 ACZONE
NDA #021794		 SUPPL-12 DAPSONE ALMIRALL Labeling Approval
11/08/2013 EMTRIVA
NDA #021896		 SUPPL-20 EMTRICITABINE GILEAD Manufacturing (CMC) Approval
11/08/2013 ATRIPLA
NDA #021937		 SUPPL-30 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Manufacturing (CMC) Approval
11/08/2013 CLEVIPREX
NDA #022156		 SUPPL-4 CLEVIDIPINE CHIESI Manufacturing (CMC) Approval
11/08/2013 RAPAFLO
NDA #022206		 SUPPL-13 SILODOSIN ABBVIE Manufacturing (CMC) Approval
11/08/2013 NEXTERONE
NDA #022325		 SUPPL-5 AMIODARONE HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/08/2013 APTIOM
NDA #022416		 ORIG-1 ESLICARBAZEPINE ACETATE SUMITOMO PHARMA AM Type 1 - New Molecular Entity Approval
11/08/2013 PHENTERMINE HYDROCHLORIDE
ANDA #040190		 SUPPL-15 PHENTERMINE HYDROCHLORIDE ELITE LABS INC Manufacturing (CMC) Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #076822		 ORIG-1 RABEPRAZOLE SODIUM TEVA PHARMS USA Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #076824		 ORIG-1 RABEPRAZOLE SODIUM DR REDDYS Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #076885		 ORIG-1 RABEPRAZOLE SODIUM PHARMOBEDIENT Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #078964		 ORIG-1 RABEPRAZOLE SODIUM CHARTWELL RX Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #090678		 ORIG-1 RABEPRAZOLE SODIUM LANNETT CO INC Approval
11/08/2013 TERBUTALINE SULFATE
ANDA #200122		 ORIG-1 TERBUTALINE SULFATE AREVA PHARMS Approval
11/08/2013 ZIDOVUDINE
NDA #200732		 SUPPL-1 ZIDOVUDINE PHARMOBEDIENT Manufacturing (CMC) Approval
11/08/2013 FELODIPINE
ANDA #201964		 ORIG-1 FELODIPINE HERITAGE Approval
11/08/2013 AMYVID
NDA #202008		 SUPPL-19 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
11/08/2013 COMPLERA
NDA #202123		 SUPPL-14 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
11/08/2013 JUVISYNC
NDA #202343		 SUPPL-9 SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Manufacturing (CMC) Approval
11/08/2013 RABEPRAZOLE SODIUM
ANDA #202376		 ORIG-1 RABEPRAZOLE SODIUM TORRENT Approval
11/08/2013 LINZESS
NDA #202811		 SUPPL-2 LINACLOTIDE ABBVIE Manufacturing (CMC) Approval
11/08/2013 STRIBILD
NDA #203100		 SUPPL-8 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
11/08/2013 XELJANZ
NDA #203214		 SUPPL-6 TOFACITINIB CITRATE PF PRISM CV REMS Approval
11/12/2013 VALSTAR PRESERVATIVE FREE
NDA #020892		 SUPPL-17 VALRUBICIN ENDO OPERATIONS Manufacturing (CMC) Approval
11/12/2013 ACTOS
NDA #021073		 SUPPL-46 PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
11/12/2013 RANEXA
NDA #021526		 SUPPL-25 RANOLAZINE MENARINI INTL Labeling Approval
11/12/2013 DUETACT
NDA #021925		 SUPPL-6 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
11/12/2013 DUETACT
NDA #021925		 SUPPL-14 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
11/12/2013 ACTOPLUS MET XR
NDA #022024		 SUPPL-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
11/12/2013 MOZOBIL
NDA #022311		 SUPPL-14 PLERIXAFOR GENZYME Manufacturing (CMC) Approval
11/12/2013 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #090834		 ORIG-1 OCTREOTIDE ACETATE SAGENT PHARMS INC Approval
11/12/2013 OCTREOTIDE ACETATE
ANDA #091041		 ORIG-1 OCTREOTIDE ACETATE SAGENT PHARMS INC Approval
11/12/2013 METHYLPHENIDATE HYDROCHLORIDE
ANDA #201466		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE NOVITIUM PHARMA Approval
11/13/2013 SAIZEN
BLA #019764		 SUPPL-59 SOMATROPIN EMD SERONO Approval
11/13/2013 GLUCOPHAGE
NDA #020357		 SUPPL-36 METFORMIN HYDROCHLORIDE EMD SERONO INC Manufacturing (CMC) Approval
11/13/2013 VISTIDE
NDA #020638		 SUPPL-11 CIDOFOVIR GILEAD SCIENCES INC Manufacturing (CMC) Approval
11/13/2013 LAMISIL AT
NDA #021124		 SUPPL-13 TERBINAFINE HYDROCHLORIDE KARO HLTHCARE Labeling Approval
11/13/2013 SIMPONI
BLA #125289		 SUPPL-94 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
11/13/2013 IMBRUVICA
NDA #205552		 ORIG-1 IBRUTINIB PHARMACYCLICS LLC Type 1 - New Molecular Entity Approval
11/14/2013 ATROPEN
NDA #017106		 SUPPL-45 ATROPINE MMT Manufacturing (CMC) Approval
11/14/2013 DILAUDID
NDA #019891		 SUPPL-16 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
11/14/2013 LEVULAN
NDA #020965		 SUPPL-13 AMINOLEVULINIC ACID HYDROCHLORIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
11/14/2013 NAMENDA
NDA #021487		 SUPPL-18 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
11/14/2013 ZORTRESS
NDA #021560		 SUPPL-13 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
11/14/2013 BESIVANCE
NDA #022308		 SUPPL-7 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
11/14/2013 NAMENDA XR
NDA #022525		 SUPPL-3 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
11/14/2013 NITHIODOTE
NDA #201444		 SUPPL-11 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
11/14/2013 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202772		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
11/14/2013 LUZU
NDA #204153		 ORIG-1 LULICONAZOLE BAUSCH Type 1 - New Molecular Entity Approval
11/15/2013 KENALOG
NDA #012104		 SUPPL-35 TRIAMCINOLONE ACETONIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
11/15/2013 LYSODREN
NDA #016885		 SUPPL-25 MITOTANE ESTEVE Labeling Approval
11/15/2013 ACCOLATE
NDA #020547		 SUPPL-33 ZAFIRLUKAST STRIDES PHARMA INTL Labeling Approval
11/15/2013 THALOMID
NDA #020785		 SUPPL-50 THALIDOMIDE BRISTOL-MYERS REMS Approval
11/15/2013 OPTISON
NDA #020899		 SUPPL-16 ALBUMIN HUMAN GE HEALTHCARE Manufacturing (CMC) Approval
11/15/2013 REBETOL
NDA #020903		 SUPPL-52 RIBAVIRIN MERCK SHARP DOHME Labeling Approval
11/15/2013 ARIXTRA
NDA #021345		 SUPPL-31 FONDAPARINUX SODIUM MYLAN IRELAND LTD Manufacturing (CMC) Approval
11/15/2013 REBETOL
NDA #021546		 SUPPL-8 RIBAVIRIN SCHERING Labeling Approval
11/15/2013 LOVAZA
NDA #021654		 SUPPL-38 OMEGA-3-ACID ETHYL ESTERS WAYLIS THERAP Manufacturing (CMC) Approval
11/15/2013 ELOXATIN
NDA #021759		 SUPPL-17 OXALIPLATIN SANOFI AVENTIS US Manufacturing (CMC) Approval
11/15/2013 REVLIMID
NDA #021880		 SUPPL-35 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
11/15/2013 ZEGERID OTC
NDA #022281		 SUPPL-7 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Manufacturing (CMC) Approval
11/15/2013 ESCITALOPRAM OXALATE
ANDA #077512		 SUPPL-2 ESCITALOPRAM OXALATE AIPING PHARM INC Labeling Approval
11/15/2013 INTRON A
BLA #103132		 SUPPL-5178 INTERFERON ALFA-2B SCHERING Approval
11/15/2013 ENBREL
BLA #103795		 SUPPL-5531 ETANERCEPT IMMUNEX Approval
11/15/2013 PEGINTRON
BLA #103949		 SUPPL-5273 PEGINTERFERON ALFA-2B SCHERING Approval
11/15/2013 SYLATRON
BLA #103949		 SUPPL-5273 PEGINTERFERON ALFA-2B SCHERING Approval
11/15/2013 ACYCLOVIR
ANDA #202168		 ORIG-1 ACYCLOVIR CADILA PHARMS LTD Approval
11/15/2013 POMALYST
NDA #204026		 SUPPL-2 POMALIDOMIDE BRISTOL REMS Approval
11/18/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-41 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
11/18/2013 SAIZEN
BLA #019764		 SUPPL-71 SOMATROPIN EMD SERONO Approval
11/18/2013 COARTEM
NDA #022268		 SUPPL-7 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
11/18/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075747		 SUPPL-12 CIPROFLOXACIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/18/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075747		 SUPPL-13 CIPROFLOXACIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/18/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075747		 SUPPL-14 CIPROFLOXACIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/18/2013 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075747		 SUPPL-15 CIPROFLOXACIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/18/2013 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE PLATINUM Approval
11/18/2013 FLUVOXAMINE MALEATE
ANDA #091482		 ORIG-2 FLUVOXAMINE MALEATE ACTAVIS ELIZABETH Approval
11/18/2013 ACAMPROSATE CALCIUM
ANDA #200143		 ORIG-1 ACAMPROSATE CALCIUM BARR LABS DIV TEVA Approval
11/18/2013 DIFICID
NDA #201699		 SUPPL-7 FIDAXOMICIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
11/18/2013 XELJANZ
NDA #203214		 SUPPL-2 TOFACITINIB CITRATE PF PRISM CV Efficacy Approval
11/19/2013 LIORESAL
NDA #020075		 SUPPL-28 BACLOFEN AMNEAL Labeling Approval
11/19/2013 FOLLISTIM AQ
BLA #021273		 SUPPL-9 FOLLITROPIN ALFA/BETA ORGANON USA INC Approval
11/19/2013 INNOPRAN XL
NDA #021438		 SUPPL-16 PROPRANOLOL HYDROCHLORIDE ANI PHARMS Labeling Approval
11/19/2013 LOCOID
NDA #022076		 SUPPL-4 HYDROCORTISONE BUTYRATE BAUSCH Manufacturing (CMC) Approval
11/19/2013 SANCUSO
NDA #022198		 SUPPL-10 GRANISETRON CUMBERLAND Manufacturing (CMC) Approval
11/19/2013 EFFIENT
NDA #022307		 SUPPL-10 PRASUGREL HYDROCHLORIDE COSETTE Labeling Approval
11/19/2013 TRAZODONE HYDROCHLORIDE
ANDA #071196		 SUPPL-63 TRAZODONE HYDROCHLORIDE APOTEX INC Labeling Approval
11/19/2013 TRAZODONE HYDROCHLORIDE
ANDA #071258		 SUPPL-40 TRAZODONE HYDROCHLORIDE APOTEX Labeling Approval
11/19/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #077809		 SUPPL-3 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE ANI PHARMS Labeling Approval
11/19/2013 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078908		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Approval
11/19/2013 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202731		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Approval
11/19/2013 MINASTRIN 24 FE
NDA #203667		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 12
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 140
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 180
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 210
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 240
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 300
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 350
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 70
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 OMNIPAQUE 9
NDA #018956		 SUPPL-92 IOHEXOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 VISIPAQUE 270
NDA #020351		 SUPPL-41 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 VISIPAQUE 320
NDA #020351		 SUPPL-41 IODIXANOL GE HEALTHCARE Manufacturing (CMC) Approval
11/20/2013 ADCIRCA
NDA #022332		 SUPPL-5 TADALAFIL ELI LILLY CO Labeling Approval
11/20/2013 HERCEPTIN
BLA #103792		 SUPPL-5305 TRASTUZUMAB GENENTECH Approval
11/20/2013 XALKORI
NDA #202570		 SUPPL-6 CRIZOTINIB PF PRISM CV Efficacy Approval
11/20/2013 LUPANETA PACK
NDA #203696		 SUPPL-2 LEUPROLIDE ACETATE; NORETHINDRONE ACETATE ABBVIE ENDOCRINE Manufacturing (CMC) Approval
11/21/2013 PROGLYCEM
NDA #017453		 SUPPL-16 DIAZOXIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
11/21/2013 DOVONEX
NDA #020554		 SUPPL-11 CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
11/21/2013 CYANOKIT
NDA #022041		 SUPPL-13 HYDROXOCOBALAMIN BTG INTL Manufacturing (CMC) Approval
11/21/2013 VPRIV
BLA #022575		 SUPPL-12 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
11/21/2013 ZIDOVUDINE
ANDA #077981		 SUPPL-16 ZIDOVUDINE CIPLA LTD Labeling Approval
11/21/2013 ZIDOVUDINE
ANDA #077981		 SUPPL-17 ZIDOVUDINE CIPLA LTD Labeling Approval
11/21/2013 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Approval
11/21/2013 GILOTRIF
NDA #201292		 SUPPL-2 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Labeling Approval
11/21/2013 ONFI
NDA #202067		 SUPPL-2 CLOBAZAM LUNDBECK PHARMS LLC Labeling Approval
11/21/2013 ONFI
NDA #203993		 SUPPL-2 CLOBAZAM LUNDBECK PHARMS LLC Labeling Approval
11/22/2013 ZAROXOLYN
NDA #017386		 SUPPL-39 METOLAZONE I3 PHARMS Manufacturing (CMC) Approval
11/22/2013 MPI DMSA KIDNEY REAGENT
NDA #017944		 SUPPL-23 TECHNETIUM TC-99M SUCCIMER KIT GE HEALTHCARE Manufacturing (CMC) Approval
11/22/2013 DEMADEX
NDA #020136		 SUPPL-26 TORSEMIDE PHARMOBEDIENT Manufacturing (CMC) Approval
11/22/2013 LANOXIN
NDA #020405		 SUPPL-10 DIGOXIN ADVANZ PHARMA Manufacturing (CMC) Approval
11/22/2013 PANRETIN
NDA #020886		 SUPPL-6 ALITRETINOIN ADVANZ PHARMA Manufacturing (CMC) Approval
11/22/2013 CUBICIN
NDA #021572		 SUPPL-43 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/22/2013 CUBICIN
NDA #021572		 SUPPL-44 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/22/2013 CUBICIN RF
NDA #021572		 SUPPL-43 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/22/2013 CUBICIN RF
NDA #021572		 SUPPL-44 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
11/22/2013 CHLORHEXIDINE GLUCONATE
NDA #021669		 SUPPL-18 CHLORHEXIDINE GLUCONATE SAGE PRODS Manufacturing (CMC) Approval
11/22/2013 NEXAVAR
NDA #021923		 SUPPL-16 SORAFENIB TOSYLATE BAYER HLTHCARE Efficacy Approval
11/22/2013 KUVAN
NDA #022181		 SUPPL-12 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Manufacturing (CMC) Approval
11/22/2013 SUBOXONE
NDA #022410		 SUPPL-15 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Labeling Approval
11/22/2013 DOXYCYCLINE HYCLATE
ANDA #062269		 SUPPL-21 DOXYCYCLINE HYCLATE EPIC PHARMA LLC Manufacturing (CMC) Approval
11/22/2013 REPAGLINIDE
ANDA #078555		 ORIG-1 REPAGLINIDE CHARTWELL RX Approval
11/22/2013 LEVOFLOXACIN
ANDA #201484		 ORIG-1 LEVOFLOXACIN WATSON LABS INC Approval
11/22/2013 SUPRAX
NDA #203195		 SUPPL-3 CEFIXIME LUPIN LTD Manufacturing (CMC) Approval
11/22/2013 SYNRIBO
NDA #203585		 SUPPL-2 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Manufacturing (CMC) Approval
11/22/2013 OLYSIO
NDA #205123		 ORIG-1 SIMEPREVIR SODIUM JANSSEN PRODS Type 1 - New Molecular Entity Approval
11/25/2013 TECHNESCAN PYP KIT
NDA #017538		 SUPPL-18 TECHNETIUM TC-99M PYROPHOSPHATE KIT CURIUM Manufacturing (CMC) Approval
11/25/2013 K-TAB
NDA #018279		 SUPPL-33 POTASSIUM CHLORIDE ABBVIE Manufacturing (CMC) Approval
11/25/2013 IMITREX
NDA #020132		 SUPPL-28 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
11/25/2013 IMITREX
NDA #020626		 SUPPL-25 SUMATRIPTAN GLAXOSMITHKLINE Labeling Approval
11/25/2013 XOPENEX HFA
NDA #021730		 SUPPL-34 LEVALBUTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
11/25/2013 VENTAVIS
NDA #021779		 SUPPL-14 ILOPROST ACTELION Labeling Approval
11/25/2013 OXALIPLATIN
NDA #022160		 SUPPL-8 OXALIPLATIN TEVA PHARMS Labeling Approval
11/25/2013 OXALIPLATIN
NDA #022160		 SUPPL-9 OXALIPLATIN TEVA PHARMS Labeling Approval
11/25/2013 SAVELLA
NDA #022256		 SUPPL-17 MILNACIPRAN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
11/25/2013 COLCRYS
NDA #022352		 SUPPL-21 COLCHICINE TAKEDA PHARMS USA Manufacturing (CMC) Approval
11/25/2013 DORYX
NDA #050795		 SUPPL-15 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
11/25/2013 DORYX MPC
NDA #050795		 SUPPL-15 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
11/25/2013 TOPIRAMATE
ANDA #091185		 ORIG-1 TOPIRAMATE HIKMA PHARMS Approval
11/25/2013 REOPRO
BLA #103575		 SUPPL-5126 ABCIXIMAB CENTOCOR INC Approval
11/25/2013 VASCEPA
NDA #202057		 SUPPL-9 ICOSAPENT ETHYL AMARIN PHARMS Labeling Approval
11/25/2013 JAKAFI
NDA #202192		 SUPPL-5 RUXOLITINIB PHOSPHATE INCYTE CORP Labeling Approval
11/25/2013 AMIODARONE HYDROCHLORIDE
ANDA #203884		 ORIG-1 AMIODARONE HYDROCHLORIDE HOSPIRA Approval
11/25/2013 AMIODARONE HYDROCHLORIDE
ANDA #203885		 ORIG-1 AMIODARONE HYDROCHLORIDE HOSPIRA Approval
11/25/2013 NOXAFIL
NDA #205053		 ORIG-1 POSACONAZOLE MERCK SHARP DOHME Type 3 - New Dosage Form Approval
11/25/2013 VARITHENA
NDA #205098		 ORIG-1 POLIDOCANOL BOSTON SCITFC Type 5 - New Formulation or New Manufacturer Approval
11/26/2013 EXELDERM
NDA #018737		 SUPPL-7 SULCONAZOLE NITRATE JOURNEY Manufacturing (CMC) Approval
11/26/2013 FORTESTA
NDA #021463		 SUPPL-11 TESTOSTERONE ENDO OPERATIONS Manufacturing (CMC) Approval
11/26/2013 SUMAVEL DOSEPRO
NDA #022239		 SUPPL-5 SUMATRIPTAN SUCCINATE ENDO OPERATIONS Efficacy Approval
11/26/2013 LEVOTHYROXINE SODIUM
NDA #202231		 SUPPL-5 LEVOTHYROXINE SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
11/26/2013 QUETIAPINE FUMARATE
ANDA #203150		 ORIG-1 QUETIAPINE FUMARATE JUBILANT GENERICS Approval
11/26/2013 INVOKANA
NDA #204042		 SUPPL-1 CANAGLIFLOZIN JANSSEN PHARMS Manufacturing (CMC) Approval
11/26/2013 RIZATRIPTAN BENZOATE
ANDA #204090		 ORIG-1 RIZATRIPTAN BENZOATE AVET LIFESCIENCES Approval
11/26/2013 ZIDOVUDINE
ANDA #204538		 ORIG-1 ZIDOVUDINE LIAONING CHENGDA Approval
11/27/2013 TRUVADA
NDA #021752		 SUPPL-33 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
11/27/2013 SOMATULINE DEPOT
NDA #022074		 SUPPL-6 LANREOTIDE ACETATE IPSEN PHARMA Labeling Approval
11/27/2013 CAPRELSA
NDA #022405		 SUPPL-5 VANDETANIB GENZYME CORP Labeling Approval
11/27/2013 VOTRIENT
NDA #022465		 SUPPL-17 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
11/27/2013 AUGMENTIN XR
NDA #050785		 SUPPL-14 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
11/27/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920		 SUPPL-5 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/27/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #078920		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/27/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #085082		 SUPPL-38 DICYCLOMINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/27/2013 DICYCLOMINE HYDROCHLORIDE
ANDA #085223		 SUPPL-44 DICYCLOMINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/27/2013 KETOROLAC TROMETHAMINE
ANDA #091065		 ORIG-1 KETOROLAC TROMETHAMINE SAGENT PHARMS INC Approval
11/27/2013 GEMCITABINE HYDROCHLORIDE
NDA #200795		 SUPPL-3 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
11/27/2013 TRAZODONE HYDROCHLORIDE
ANDA #202180		 ORIG-1 TRAZODONE HYDROCHLORIDE TORRENT Approval
11/27/2013 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #202424		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE AUROLIFE PHARMA LLC Approval
11/27/2013 VELPHORO
NDA #205109		 ORIG-1 FERRIC OXYHYDROXIDE VIFOR FRESENIUS Type 5 - New Formulation or New Manufacturer Approval
11/29/2013 KLOR-CON
NDA #019123		 SUPPL-34 POTASSIUM CHLORIDE UPSHER SMITH LABS Manufacturing (CMC) Approval
11/29/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE TEVA PHARMS Labeling Approval
11/29/2013 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090385		 SUPPL-3 LEVOCETIRIZINE DIHYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
11/29/2013 SUMATRIPTAN; NAPROXEN SODIUM
ANDA #090753		 ORIG-1 SUMATRIPTAN; NAPROXEN SODIUM PAR PHARM Tentative Approval
11/29/2013 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #200465		 ORIG-1 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM MYLAN Approval
11/30/2013 ACETAMINOPHEN
ANDA #075077		 SUPPL-32 ACETAMINOPHEN PERRIGO Labeling Approval
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