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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 2014

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 October 09, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/01/2014 LITHIUM CITRATE
NDA #018421		 SUPPL-28 LITHIUM CITRATE HIKMA PHARMS Manufacturing (CMC) Approval
07/01/2014 PREMPHASE 14/14
NDA #020527		 SUPPL-59 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Manufacturing (CMC) Approval
07/01/2014 PREMPRO
NDA #020527		 SUPPL-59 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE WYETH PHARMS Manufacturing (CMC) Approval
07/01/2014 IPRIVASK
BLA #021271		 SUPPL-5 DESIRUDIN RECOMBINANT BAUSCH Approval
07/01/2014 M.V.I. ADULT
NDA #021625		 SUPPL-17 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K HOSPIRA Manufacturing (CMC) Approval
07/01/2014 EPIDUO
NDA #022320		 SUPPL-7 ADAPALENE; BENZOYL PEROXIDE GALDERMA LABS LP Manufacturing (CMC) Approval
07/01/2014 AFINITOR
NDA #022334		 SUPPL-25 EVEROLIMUS NOVARTIS Labeling Approval
07/01/2014 TRAZODONE HYDROCHLORIDE
ANDA #071523		 SUPPL-49 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/01/2014 TRAZODONE HYDROCHLORIDE
ANDA #071524		 SUPPL-49 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/01/2014 TRAZODONE HYDROCHLORIDE
ANDA #071525		 SUPPL-53 TRAZODONE HYDROCHLORIDE PLIVA Labeling Approval
07/01/2014 PRAVASTATIN SODIUM
ANDA #077987		 SUPPL-9 PRAVASTATIN SODIUM GLENMARK PHARMS LTD Manufacturing (CMC) Approval
07/01/2014 DILANTIN
ANDA #084427		 SUPPL-31 PHENYTOIN PHARMACIA Labeling Approval
07/01/2014 TRAZODONE HYDROCHLORIDE
ANDA #090514		 SUPPL-3 TRAZODONE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/01/2014 LINZESS
NDA #202811		 SUPPL-5 LINACLOTIDE ABBVIE Manufacturing (CMC) Approval
07/01/2014 AFINITOR DISPERZ
NDA #203985		 SUPPL-7 EVEROLIMUS NOVARTIS PHARM Labeling Approval
07/02/2014 NORPRAMIN
NDA #014399		 SUPPL-69 DESIPRAMINE HYDROCHLORIDE VALIDUS PHARMS Labeling Approval
07/02/2014 QUALAQUIN
NDA #021799		 SUPPL-24 QUININE SULFATE SUN PHARM INDUSTRIES Labeling Approval
07/02/2014 LETAIRIS
NDA #022081		 SUPPL-26 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
07/02/2014 AZOR
NDA #022100		 SUPPL-25 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
07/02/2014 MORPHINE SULFATE
ANDA #079040		 SUPPL-4 MORPHINE SULFATE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
07/03/2014 SOLU-CORTEF
NDA #009866		 SUPPL-104 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
07/03/2014 ARISTOCORT
NDA #011685		 SUPPL-26 TRIAMCINOLONE DIACETATE FOSUN PHARMA Labeling Approval
07/03/2014 DEPO-MEDROL
NDA #011757		 SUPPL-103 METHYLPREDNISOLONE ACETATE PFIZER Labeling Approval
07/03/2014 SOLU-MEDROL
NDA #011856		 SUPPL-123 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
07/03/2014 KENALOG-10
NDA #012041		 SUPPL-42 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
07/03/2014 ARISTOCORT
NDA #012802		 SUPPL-33 TRIAMCINOLONE DIACETATE FOSUN PHARMA Labeling Approval
07/03/2014 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-58 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Labeling Approval
07/03/2014 KENALOG-40
NDA #014901		 SUPPL-42 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
07/03/2014 KENALOG-80
NDA #014901		 SUPPL-42 TRIAMCINOLONE ACETONIDE APOTHECON Labeling Approval
07/03/2014 ARISTOSPAN
NDA #016466		 SUPPL-46 TRIAMCINOLONE HEXACETONIDE ETHYPHARM Labeling Approval
07/03/2014 ZOLOFT
NDA #019839		 SUPPL-80 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
07/03/2014 ZOLOFT
NDA #019839		 SUPPL-83 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
07/03/2014 DOVONEX
NDA #020273		 SUPPL-12 CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
07/03/2014 ZOLOFT
NDA #020990		 SUPPL-39 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
07/03/2014 ZOLOFT
NDA #020990		 SUPPL-41 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
07/03/2014 TRILEPTAL
NDA #021014		 SUPPL-33 OXCARBAZEPINE NOVARTIS Labeling Approval
07/03/2014 RAPAMUNE
NDA #021110		 SUPPL-71 SIROLIMUS PF PRISM CV Manufacturing (CMC) Approval
07/03/2014 TRILEPTAL
NDA #021285		 SUPPL-27 OXCARBAZEPINE NOVARTIS Labeling Approval
07/03/2014 BENICAR
NDA #021286		 SUPPL-29 OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
07/03/2014 IMPLANON
NDA #021529		 SUPPL-8 ETONOGESTREL ORGANON Labeling Approval
07/03/2014 NEXPLANON
NDA #021529		 SUPPL-8 ETONOGESTREL ORGANON Labeling Approval
07/03/2014 DIGOXIN
NDA #021648		 SUPPL-7 DIGOXIN HIKMA PHARMS Manufacturing (CMC) Approval
07/03/2014 CYANOKIT
NDA #022041		 SUPPL-15 HYDROXOCOBALAMIN BTG INTL Manufacturing (CMC) Approval
07/03/2014 TRELSTAR
NDA #022437		 SUPPL-9 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
07/03/2014 NAMENDA XR
NDA #022525		 SUPPL-5 MEMANTINE HYDROCHLORIDE ABBVIE Efficacy Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #040491		 SUPPL-8 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040572		 SUPPL-2 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040802		 SUPPL-7 DEXAMETHASONE SODIUM PHOSPHATE MYLAN LABS LTD Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040803		 SUPPL-7 DEXAMETHASONE SODIUM PHOSPHATE MYLAN LABS LTD Labeling Approval
07/03/2014 FENTANYL-100
ANDA #077775		 SUPPL-12 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-100
ANDA #077775		 SUPPL-16 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-25
ANDA #077775		 SUPPL-12 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-25
ANDA #077775		 SUPPL-16 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-50
ANDA #077775		 SUPPL-12 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-50
ANDA #077775		 SUPPL-16 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-75
ANDA #077775		 SUPPL-12 FENTANYL NOVEN Labeling Approval
07/03/2014 FENTANYL-75
ANDA #077775		 SUPPL-16 FENTANYL NOVEN Labeling Approval
07/03/2014 MORPHINE SULFATE
ANDA #079040		 SUPPL-5 MORPHINE SULFATE ACTAVIS ELIZABETH Labeling Approval
07/03/2014 DILANTIN
ANDA #084349		 SUPPL-73 PHENYTOIN SODIUM VIATRIS Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916		 SUPPL-66 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087440		 SUPPL-27 DEXAMETHASONE SODIUM PHOSPHATE LUITPOLD Labeling Approval
07/03/2014 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702		 SUPPL-36 DEXAMETHASONE SODIUM PHOSPHATE HIKMA PHARMS Labeling Approval
07/03/2014 CLONIDINE HYDROCHLORIDE
ANDA #090329		 ORIG-1 CLONIDINE HYDROCHLORIDE SUN PHARM INDS INC Approval
07/03/2014 DOCETAXEL
NDA #201195		 SUPPL-6 DOCETAXEL ACCORD HLTHCARE Labeling Approval
07/03/2014 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
ANDA #203200		 ORIG-1 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PERRIGO R AND D Approval
07/03/2014 ILEVRO
NDA #203491		 SUPPL-6 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
07/03/2014 FLUPHENAZINE DECANOATE
ANDA #203732		 ORIG-1 FLUPHENAZINE DECANOATE PH HEALTH Approval
07/03/2014 ZOLEDRONIC ACID
ANDA #204051		 ORIG-1 ZOLEDRONIC ACID SUN PHARMA GLOBAL Tentative Approval
07/03/2014 BELEODAQ
NDA #206256		 ORIG-1 BELINOSTAT ACROTECH BIOPHARMA Type 1 - New Molecular Entity Approval
07/07/2014 INDIUM IN 111 OXYQUINOLINE
NDA #019044		 SUPPL-23 INDIUM IN-111 OXYQUINOLINE GE HEALTHCARE Manufacturing (CMC) Approval
07/07/2014 EFFEXOR XR
NDA #020699		 SUPPL-103 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
07/07/2014 EFFEXOR XR
NDA #020699		 SUPPL-105 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
07/07/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #077166		 SUPPL-11 VENLAFAXINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/07/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #077166		 SUPPL-13 VENLAFAXINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/07/2014 TELMISARTAN
ANDA #090032		 ORIG-1 TELMISARTAN GLENMARK PHARMS LTD Approval
07/07/2014 TELMISARTAN
ANDA #202130		 ORIG-1 TELMISARTAN ALEMBIC Approval
07/07/2014 TELMISARTAN
ANDA #202397		 ORIG-1 TELMISARTAN MYLAN Approval
07/07/2014 MARQIBO KIT
NDA #202497		 SUPPL-1 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
07/07/2014 TELMISARTAN
ANDA #203171		 ORIG-1 TELMISARTAN TORRENT Approval
07/07/2014 DESVENLAFAXINE
NDA #204150		 SUPPL-1 DESVENLAFAXINE ALEMBIC PHARMS LTD Labeling Approval
07/07/2014 DESVENLAFAXINE
NDA #204150		 SUPPL-2 DESVENLAFAXINE ALEMBIC PHARMS LTD Labeling Approval
07/07/2014 KERYDIN
NDA #204427		 ORIG-1 TAVABOROLE ANACOR PHARMS INC Type 1 - New Molecular Entity Approval
07/08/2014 CONRAY
NDA #013295		 SUPPL-66 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Labeling Approval
07/08/2014 CONRAY 43
NDA #013295		 SUPPL-66 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Labeling Approval
07/08/2014 CELEXA
NDA #020822		 SUPPL-46 CITALOPRAM HYDROBROMIDE ABBVIE Labeling Approval
07/08/2014 LEXAPRO
NDA #021323		 SUPPL-45 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
07/08/2014 LEXAPRO
NDA #021365		 SUPPL-33 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
07/08/2014 CRESTOR
NDA #021366		 SUPPL-30 ROSUVASTATIN CALCIUM ASTRAZENECA Labeling Approval
07/08/2014 VANTAS
NDA #021732		 SUPPL-19 HISTRELIN ACETATE ENDO OPERATIONS Labeling Approval
07/08/2014 RIBAVIRIN
ANDA #076192		 SUPPL-16 RIBAVIRIN CHARTWELL RX Labeling Approval
07/08/2014 RIBAVIRIN
ANDA #076192		 SUPPL-17 RIBAVIRIN CHARTWELL RX Labeling Approval
07/08/2014 RIBAVIRIN
ANDA #076192		 SUPPL-18 RIBAVIRIN CHARTWELL RX Labeling Approval
07/08/2014 GEMCITABINE HYDROCHLORIDE
ANDA #079160		 SUPPL-5 GEMCITABINE HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
07/08/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #090485		 SUPPL-9 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
07/08/2014 VALCHLOR
NDA #202317		 SUPPL-2 MECHLORETHAMINE HYDROCHLORIDE HELSINN Manufacturing (CMC) Approval
07/09/2014 FORTICAL
NDA #021406		 SUPPL-17 CALCITONIN SALMON RECOMBINANT UPSHER SMITH LABS Labeling Approval
07/09/2014 FORTICAL
NDA #021406		 SUPPL-22 CALCITONIN SALMON RECOMBINANT UPSHER SMITH LABS Labeling Approval
07/09/2014 APLENZIN
NDA #022108		 SUPPL-11 BUPROPION HYDROBROMIDE BAUSCH Labeling Approval
07/09/2014 CAYSTON
NDA #050814		 SUPPL-12 AZTREONAM GILEAD Manufacturing (CMC) Approval
07/09/2014 VALCHLOR
NDA #202317		 SUPPL-1 MECHLORETHAMINE HYDROCHLORIDE HELSINN Labeling Approval
07/09/2014 LINZESS
NDA #202811		 SUPPL-4 LINACLOTIDE ABBVIE Labeling Approval
07/10/2014 TOFRANIL-PM
NDA #017090		 SUPPL-77 IMIPRAMINE PAMOATE SPECGX LLC Labeling Approval
07/10/2014 PAMELOR
NDA #018012		 SUPPL-30 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/10/2014 PAMELOR
NDA #018013		 SUPPL-62 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/10/2014 LUPRON
NDA #019010		 SUPPL-37 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
07/10/2014 ANAFRANIL
NDA #019906		 SUPPL-38 CLOMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/10/2014 RESCULA
NDA #021214		 SUPPL-8 UNOPROSTONE ISOPROPYL SUCAMPO PHARMA LLC Manufacturing (CMC) Approval
07/10/2014 NAMENDA
NDA #021627		 SUPPL-11 MEMANTINE HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
07/10/2014 DOCETAXEL
NDA #022234		 SUPPL-3 DOCETAXEL HOSPIRA INC Efficacy Approval
07/10/2014 DOXYCYCLINE
ANDA #065055		 SUPPL-13 DOXYCYCLINE STRIDES PHARMA INTL Labeling Approval
07/10/2014 IBUPROFEN
ANDA #076460		 SUPPL-4 IBUPROFEN AVEMA PHARMA Labeling Approval
07/10/2014 QNASL
NDA #202813		 SUPPL-6 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Labeling Approval
07/10/2014 PENNSAID
NDA #204623		 SUPPL-2 DICLOFENAC SODIUM HORIZON Manufacturing (CMC) Approval
07/10/2014 RASUVO
NDA #205776		 ORIG-1 METHOTREXATE MEDEXUS Type 5 - New Formulation or New Manufacturer Approval
07/11/2014 RYTHMOL
NDA #019151		 SUPPL-13 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Manufacturing (CMC) Approval
07/11/2014 TRELSTAR
NDA #020715		 SUPPL-32 TRIPTORELIN PAMOATE VERITY Labeling Approval
07/11/2014 TRELSTAR
NDA #021288		 SUPPL-28 TRIPTORELIN PAMOATE VERITY Labeling Approval
07/11/2014 BRAVELLE
BLA #021289		 SUPPL-21 UROFOLLITROPIN FERRING Approval
07/11/2014 RYTHMOL SR
NDA #021416		 SUPPL-13 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Manufacturing (CMC) Approval
07/11/2014 WELLBUTRIN XL
NDA #021515		 SUPPL-32 BUPROPION HYDROCHLORIDE BAUSCH Labeling Approval
07/11/2014 MENOPUR
BLA #021663		 SUPPL-19 MENOTROPINS (FSH;LH) FERRING Approval
07/11/2014 TRUVADA
NDA #021752		 SUPPL-45 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing (CMC) Approval
07/11/2014 ATRIPLA
NDA #021937		 SUPPL-32 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Manufacturing (CMC) Approval
07/11/2014 TRELSTAR
NDA #022437		 SUPPL-8 TRIPTORELIN PAMOATE VERITY Labeling Approval
07/11/2014 VPRIV
BLA #022575		 SUPPL-10 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
07/11/2014 GENTAMICIN SULFATE
ANDA #065121		 SUPPL-2 GENTAMICIN SULFATE PADAGIS US Manufacturing (CMC) Approval
07/11/2014 TRAZODONE HYDROCHLORIDE
ANDA #071523		 SUPPL-50 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/11/2014 TRAZODONE HYDROCHLORIDE
ANDA #071524		 SUPPL-50 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/11/2014 TRAZODONE HYDROCHLORIDE
ANDA #071525		 SUPPL-54 TRAZODONE HYDROCHLORIDE PLIVA Labeling Approval
07/11/2014 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #077184		 SUPPL-11 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/11/2014 CITALOPRAM HYDROBROMIDE
ANDA #077601		 SUPPL-3 CITALOPRAM HYDROBROMIDE PHARM ASSOC Labeling Approval
07/11/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #079098		 SUPPL-2 VENLAFAXINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
07/11/2014 FLUOXETINE HYDROCHLORIDE
ANDA #079209		 SUPPL-3 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/11/2014 FLUOXETINE HYDROCHLORIDE
ANDA #079209		 SUPPL-4 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/11/2014 KADCYLA
BLA #125427		 SUPPL-33 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
07/11/2014 COMPLERA
NDA #202123		 SUPPL-17 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
07/14/2014 RITALIN
NDA #010187		 SUPPL-78 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
07/14/2014 SINEQUAN
NDA #016798		 SUPPL-56 DOXEPIN HYDROCHLORIDE PFIZER Labeling Approval
07/14/2014 SINEQUAN
NDA #017516		 SUPPL-25 DOXEPIN HYDROCHLORIDE PFIZER Labeling Approval
07/14/2014 OMNITROPE
BLA #021426		 SUPPL-29 SOMATROPIN SANDOZ Approval
07/14/2014 FLUOCINONIDE
ANDA #091282		 ORIG-1 FLUOCINONIDE GLENMARK PHARMS LTD Approval
07/14/2014 FLUOCINONIDE
ANDA #200734		 ORIG-1 FLUOCINONIDE SUN PHARMA CANADA Approval
07/14/2014 FLUOCINONIDE
ANDA #200735		 ORIG-1 FLUOCINONIDE FOUGERA PHARMS INC Approval
07/15/2014 DEMSER
NDA #017871		 SUPPL-19 METYROSINE BAUSCH Manufacturing (CMC) Approval
07/15/2014 SODIUM LACTATE IN PLASTIC CONTAINER
NDA #018947		 SUPPL-24 SODIUM LACTATE HOSPIRA Manufacturing (CMC) Approval
07/15/2014 TRELSTAR
NDA #020715		 SUPPL-33 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
07/15/2014 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-24 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Labeling Approval
07/15/2014 TRELSTAR
NDA #021288		 SUPPL-29 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
07/15/2014 ARIXTRA
NDA #021345		 SUPPL-32 FONDAPARINUX SODIUM MYLAN IRELAND LTD Labeling Approval
07/15/2014 SANCUSO
NDA #022198		 SUPPL-11 GRANISETRON APOTEX Manufacturing (CMC) Approval
07/15/2014 SOLODYN
NDA #050808		 SUPPL-21 MINOCYCLINE HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
07/15/2014 LEVOFLOXACIN
ANDA #076361		 SUPPL-1 LEVOFLOXACIN TEVA Manufacturing (CMC) Approval
07/15/2014 CITALOPRAM HYDROBROMIDE
ANDA #077812		 SUPPL-10 CITALOPRAM HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
07/15/2014 MORPHINE SULFATE
ANDA #202104		 SUPPL-2 MORPHINE SULFATE UPSHER SMITH LABS Labeling Approval
07/15/2014 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #205292		 ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE PADAGIS US Approval
07/16/2014 HEXADROL
NDA #014694		 SUPPL-30 DEXAMETHASONE SODIUM PHOSPHATE ASPEN GLOBAL INC Labeling Approval
07/16/2014 BACTRIM
NDA #017377		 SUPPL-74 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/16/2014 BACTRIM DS
NDA #017377		 SUPPL-74 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Labeling Approval
07/16/2014 PROMACTA
NDA #022291		 SUPPL-13 ELTROMBOPAG OLAMINE NOVARTIS REMS Approval
07/16/2014 VIIBRYD
NDA #022567		 SUPPL-13 VILAZODONE HYDROCHLORIDE ABBVIE Labeling Approval
07/16/2014 PENICILLIN-VK
ANDA #060456		 SUPPL-52 PENICILLIN V POTASSIUM CHARTWELL RX Labeling Approval
07/16/2014 PENICILLIN-VK
ANDA #060711		 SUPPL-39 PENICILLIN V POTASSIUM CHARTWELL RX Labeling Approval
07/16/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075872		 SUPPL-17 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
07/16/2014 FLUOXETINE HYDROCHLORIDE
ANDA #077849		 SUPPL-6 FLUOXETINE HYDROCHLORIDE LANNETT CO INC Labeling Approval
07/16/2014 KHEDEZLA
NDA #204683		 SUPPL-2 DESVENLAFAXINE OSMOTICA PHARM CORP Labeling Approval
07/17/2014 VIVACTIL
NDA #016012		 SUPPL-53 PROTRIPTYLINE HYDROCHLORIDE TEVA WOMENS Labeling Approval
07/17/2014 SURMONTIL
NDA #016792		 SUPPL-37 TRIMIPRAMINE MALEATE TEVA WOMENS Labeling Approval
07/17/2014 SINEMET
NDA #017555		 SUPPL-56 CARBIDOPA; LEVODOPA ORGANON Labeling Approval
07/17/2014 SINEMET
NDA #017555		 SUPPL-68 CARBIDOPA; LEVODOPA ORGANON Labeling Approval
07/17/2014 SINEMET
NDA #017555		 SUPPL-71 CARBIDOPA; LEVODOPA ORGANON Labeling Approval
07/17/2014 DESYREL
NDA #018207		 SUPPL-31 TRAZODONE HYDROCHLORIDE PRAGMA Labeling Approval
07/17/2014 WELLBUTRIN
NDA #018644		 SUPPL-49 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
07/17/2014 EPI E Z PEN JR
NDA #019430		 SUPPL-58 EPINEPHRINE VIATRIS Labeling Approval
07/17/2014 EPIPEN
NDA #019430		 SUPPL-58 EPINEPHRINE VIATRIS Labeling Approval
07/17/2014 EPIPEN E Z PEN
NDA #019430		 SUPPL-58 EPINEPHRINE VIATRIS Labeling Approval
07/17/2014 EPIPEN JR.
NDA #019430		 SUPPL-58 EPINEPHRINE VIATRIS Labeling Approval
07/17/2014 ADAGEN
BLA #019818		 SUPPL-55 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
07/17/2014 SINEMET CR
NDA #019856		 SUPPL-16 CARBIDOPA; LEVODOPA ORGANON LLC Labeling Approval
07/17/2014 SINEMET CR
NDA #019856		 SUPPL-24 CARBIDOPA; LEVODOPA ORGANON LLC Labeling Approval
07/17/2014 SINEMET CR
NDA #019856		 SUPPL-28 CARBIDOPA; LEVODOPA ORGANON LLC Labeling Approval
07/17/2014 WELLBUTRIN SR
NDA #020358		 SUPPL-56 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
07/17/2014 SANDOSTATIN LAR
NDA #021008		 SUPPL-30 OCTREOTIDE ACETATE NOVARTIS Manufacturing (CMC) Approval
07/17/2014 CYMBALTA
NDA #021427		 SUPPL-45 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
07/17/2014 PRISTIQ
NDA #021992		 SUPPL-40 DESVENLAFAXINE SUCCINATE PF PRISM CV Labeling Approval
07/17/2014 OLEPTRO
NDA #022411		 SUPPL-8 TRAZODONE HYDROCHLORIDE ANGELINI PHARMA Labeling Approval
07/17/2014 FORFIVO XL
NDA #022497		 SUPPL-2 BUPROPION HYDROCHLORIDE TWI PHARMS Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #040218		 SUPPL-19 AMITRIPTYLINE HYDROCHLORIDE PH HEALTH Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #040816		 SUPPL-5 AMITRIPTYLINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/17/2014 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-31 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070297		 SUPPL-27 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #070791		 SUPPL-27 DOXEPIN HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #070825		 SUPPL-12 DOXEPIN HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #070827		 SUPPL-14 DOXEPIN HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #070828		 SUPPL-14 DOXEPIN HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071077		 SUPPL-28 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071078		 SUPPL-25 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071079		 SUPPL-27 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071238		 SUPPL-26 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071239		 SUPPL-26 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071297		 SUPPL-30 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE MYLAN PHARMS INC Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071326		 SUPPL-26 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #071405		 SUPPL-5 TRAZODONE HYDROCHLORIDE NATCO Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #071406		 SUPPL-5 TRAZODONE HYDROCHLORIDE NATCO Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071422		 SUPPL-30 DOXEPIN HYDROCHLORIDE PH HEALTH Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071437		 SUPPL-35 DOXEPIN HYDROCHLORIDE PAR PHARM Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071443		 SUPPL-28 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE MYLAN Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071485		 SUPPL-27 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071486		 SUPPL-27 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071487		 SUPPL-14 DOXEPIN HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071502		 SUPPL-13 DOXEPIN HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #071514		 SUPPL-21 TRAZODONE HYDROCHLORIDE ALVOGEN Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071521		 SUPPL-13 DOXEPIN HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071562		 SUPPL-14 DOXEPIN HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071609		 SUPPL-28 DOXEPIN HYDROCHLORIDE TEVA PHARMS Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #071636		 SUPPL-29 TRAZODONE HYDROCHLORIDE ALVOGEN Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071653		 SUPPL-13 DOXEPIN HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071654		 SUPPL-13 DOXEPIN HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #071918		 SUPPL-14 DOXEPIN HYDROCHLORIDE PHARMOBEDIENT CNSLTG Labeling Approval
07/17/2014 MAPROTILINE HYDROCHLORIDE
ANDA #072162		 SUPPL-10 MAPROTILINE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
07/17/2014 MAPROTILINE HYDROCHLORIDE
ANDA #072163		 SUPPL-9 MAPROTILINE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
07/17/2014 MAPROTILINE HYDROCHLORIDE
ANDA #072164		 SUPPL-10 MAPROTILINE HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072277		 SUPPL-11 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
07/17/2014 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #072278		 SUPPL-11 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE CHARTWELL RX Labeling Approval
07/17/2014 MAPROTILINE HYDROCHLORIDE
ANDA #072285		 SUPPL-21 MAPROTILINE HYDROCHLORIDE RISING Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072418		 SUPPL-15 AMOXAPINE WATSON PHARMS TEVA Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072419		 SUPPL-15 AMOXAPINE WATSON PHARMS TEVA Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072420		 SUPPL-15 AMOXAPINE WATSON PHARMS TEVA Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072421		 SUPPL-15 AMOXAPINE WATSON PHARMS TEVA Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072691		 SUPPL-36 AMOXAPINE WATSON LABS Labeling Approval
07/17/2014 AMOXAPINE
ANDA #072879		 SUPPL-14 AMOXAPINE CHARTWELL RX Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #072985		 SUPPL-17 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #072986		 SUPPL-17 DOXEPIN HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #072987		 SUPPL-17 DOXEPIN HYDROCHLORIDE WATSON LABS TEVA Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073007		 SUPPL-24 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073008		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073009		 SUPPL-24 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
07/17/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073010		 SUPPL-24 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #073137		 SUPPL-34 TRAZODONE HYDROCHLORIDE SUN PHARM INDUSTRIES Labeling Approval
07/17/2014 VIVACTIL
ANDA #073644		 SUPPL-23 PROTRIPTYLINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
07/17/2014 VIVACTIL
ANDA #073645		 SUPPL-28 PROTRIPTYLINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
07/17/2014 DOXEPIN HYDROCHLORIDE
ANDA #074721		 SUPPL-11 DOXEPIN HYDROCHLORIDE LANNETT CO INC Labeling Approval
07/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075506		 SUPPL-20 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
07/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075920		 SUPPL-15 FLUOXETINE HYDROCHLORIDE BAJAJ Labeling Approval
07/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076006		 SUPPL-4 FLUOXETINE HYDROCHLORIDE DR REDDYS Labeling Approval
07/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076024		 SUPPL-2 FLUOXETINE HYDROCHLORIDE FOSUN PHARMA Labeling Approval
07/17/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076037		 SUPPL-11 NEFAZODONE HYDROCHLORIDE TEVA Labeling Approval
07/17/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076072		 SUPPL-3 NEFAZODONE HYDROCHLORIDE ANI PHARMS Labeling Approval
07/17/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076073		 SUPPL-4 NEFAZODONE HYDROCHLORIDE WATSON LABS Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #076690		 SUPPL-20 VENLAFAXINE HYDROCHLORIDE TEVA Labeling Approval
07/17/2014 CITALOPRAM HYDROBROMIDE
ANDA #077043		 SUPPL-10 CITALOPRAM HYDROBROMIDE HIKMA PHARMS Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #077166		 SUPPL-14 VENLAFAXINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #077515		 SUPPL-1 VENLAFAXINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
07/17/2014 CITALOPRAM HYDROBROMIDE
ANDA #077601		 SUPPL-4 CITALOPRAM HYDROBROMIDE PHARM ASSOC Labeling Approval
07/17/2014 CITALOPRAM HYDROBROMIDE
ANDA #077629		 SUPPL-11 CITALOPRAM HYDROBROMIDE CHARTWELL MOLECULAR Labeling Approval
07/17/2014 ESCITALOPRAM OXALATE
ANDA #077660		 SUPPL-4 ESCITALOPRAM OXALATE RISING Labeling Approval
07/17/2014 CITALOPRAM HYDROBROMIDE
ANDA #077668		 SUPPL-6 CITALOPRAM HYDROBROMIDE PHARMOBEDIENT Labeling Approval
07/17/2014 CITALOPRAM HYDROBROMIDE
ANDA #077812		 SUPPL-11 CITALOPRAM HYDROBROMIDE AUROBINDO PHARMA Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078301		 SUPPL-7 VENLAFAXINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078554		 SUPPL-4 VENLAFAXINE HYDROCHLORIDE HERITAGE Labeling Approval
07/17/2014 ROPIVACAINE HYDROCHLORIDE
ANDA #078601		 ORIG-1 ROPIVACAINE HYDROCHLORIDE NAVINTA LLC Approval
07/17/2014 PROTRIPTYLINE HYDROCHLORIDE
ANDA #078913		 SUPPL-2 PROTRIPTYLINE HYDROCHLORIDE HIKMA PHARMS Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078932		 SUPPL-4 VENLAFAXINE HYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #079098		 SUPPL-3 VENLAFAXINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
07/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #079209		 SUPPL-6 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #083745		 SUPPL-121 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #084936		 SUPPL-107 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #084937		 SUPPL-127 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085968		 SUPPL-96 AMITRIPTYLINE HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #085970		 SUPPL-72 AMITRIPTYLINE HYDROCHLORIDE SANDOZ Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #086009		 SUPPL-66 AMITRIPTYLINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
07/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #087846		 SUPPL-28 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/17/2014 TOFRANIL
ANDA #087846		 SUPPL-28 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/17/2014 AMITRIPTYLINE HYDROCHLORIDE
ANDA #089399		 SUPPL-39 AMITRIPTYLINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #090027		 SUPPL-9 VENLAFAXINE HYDROCHLORIDE PRINSTON INC Labeling Approval
07/17/2014 IMIPRAMINE HYDROCHLORIDE
ANDA #090441		 SUPPL-6 IMIPRAMINE HYDROCHLORIDE CHARTWELL Labeling Approval
07/17/2014 PROTRIPTYLINE HYDROCHLORIDE
ANDA #090462		 SUPPL-3 PROTRIPTYLINE HYDROCHLORIDE SIGMAPHARM LABS LLC Labeling Approval
07/17/2014 TRAZODONE HYDROCHLORIDE
ANDA #090514		 SUPPL-4 TRAZODONE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
07/17/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #090555		 SUPPL-9 VENLAFAXINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
07/17/2014 PHENELZINE SULFATE
ANDA #200181		 SUPPL-2 PHENELZINE SULFATE NOVEL LABS INC Labeling Approval
07/17/2014 PROTRIPTYLINE HYDROCHLORIDE
ANDA #202220		 SUPPL-1 PROTRIPTYLINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
07/17/2014 TUDORZA PRESSAIR
NDA #202450		 SUPPL-2 ACLIDINIUM BROMIDE AZURITY Labeling Approval
07/17/2014 TRINTELLIX
NDA #204447		 SUPPL-5 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Labeling Approval
07/18/2014 KINEVAC
NDA #017697		 SUPPL-23 SINCALIDE BRACCO Manufacturing (CMC) Approval
07/18/2014 PROZAC
NDA #018936		 SUPPL-105 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
07/18/2014 SARAFEM
NDA #018936		 SUPPL-105 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
07/18/2014 PAXIL
NDA #020031		 SUPPL-71 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/18/2014 REMERON
NDA #020415		 SUPPL-31 MIRTAZAPINE ORGANON Labeling Approval
07/18/2014 ELLIOTTS B SOLUTION
NDA #020577		 SUPPL-8 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE LUKARE MEDICAL LLC Manufacturing (CMC) Approval
07/18/2014 PAXIL
NDA #020710		 SUPPL-35 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/18/2014 PAXIL CR
NDA #020936		 SUPPL-49 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/18/2014 REMERON SOLTAB
NDA #021208		 SUPPL-21 MIRTAZAPINE ORGANON USA ORGANON Labeling Approval
07/18/2014 PROZAC WEEKLY
NDA #021235		 SUPPL-24 FLUOXETINE HYDROCHLORIDE LILLY Labeling Approval
07/18/2014 BRAVELLE
BLA #021289		 SUPPL-22 UROFOLLITROPIN FERRING Approval
07/18/2014 PEXEVA
NDA #021299		 SUPPL-32 PAROXETINE MESYLATE SEBELA IRELAND LTD Labeling Approval
07/18/2014 ELIGARD KIT
NDA #021343		 SUPPL-28 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
07/18/2014 OXYTROL
NDA #021351		 SUPPL-15 OXYBUTYNIN ALLERGAN Manufacturing (CMC) Approval
07/18/2014 ELIGARD KIT
NDA #021379		 SUPPL-26 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
07/18/2014 STALEVO 100
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 100
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 125
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 125
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 150
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 150
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 200
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 200
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 50
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 50
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 75
NDA #021485		 SUPPL-28 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 STALEVO 75
NDA #021485		 SUPPL-29 CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA Labeling Approval
07/18/2014 LUVOX
NDA #021519		 SUPPL-8 FLUVOXAMINE MALEATE ANI PHARMS Labeling Approval
07/18/2014 SYMBYAX
NDA #021520		 SUPPL-45 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Labeling Approval
07/18/2014 ELIGARD KIT
NDA #021731		 SUPPL-24 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
07/18/2014 VYVANSE
NDA #021977		 SUPPL-31 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
07/18/2014 VYVANSE
NDA #021977		 SUPPL-32 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
07/18/2014 LUVOX CR
NDA #022033		 SUPPL-10 FLUVOXAMINE MALEATE JAZZ PHARMS Labeling Approval
07/18/2014 VENLAFAXINE HYDROCHLORIDE
NDA #022104		 SUPPL-10 VENLAFAXINE HYDROCHLORIDE OSMOTICA PHARM US Labeling Approval
07/18/2014 BRILINTA
NDA #022433		 SUPPL-12 TICAGRELOR ASTRAZENECA Manufacturing (CMC) Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #070857		 SUPPL-46 TRAZODONE HYDROCHLORIDE WATSON LABS Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #070858		 SUPPL-46 TRAZODONE HYDROCHLORIDE WATSON LABS Labeling Approval
07/18/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071062		 SUPPL-22 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
07/18/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071063		 SUPPL-22 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
07/18/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071064		 SUPPL-17 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #071523		 SUPPL-51 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #071524		 SUPPL-51 TRAZODONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #071525		 SUPPL-55 TRAZODONE HYDROCHLORIDE PLIVA Labeling Approval
07/18/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071862		 SUPPL-16 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE FOSUN PHARMA Labeling Approval
07/18/2014 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071863		 SUPPL-16 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #072483		 SUPPL-12 TRAZODONE HYDROCHLORIDE AIPING PHARM INC Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #072484		 SUPPL-14 TRAZODONE HYDROCHLORIDE RISING Labeling Approval
07/18/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075872		 SUPPL-18 FLUOXETINE HYDROCHLORIDE TEVA Labeling Approval
07/18/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076129		 SUPPL-2 NEFAZODONE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
07/18/2014 NEFAZODONE HYDROCHLORIDE
ANDA #076309		 SUPPL-4 NEFAZODONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
07/18/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #077653		 SUPPL-9 VENLAFAXINE HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
07/18/2014 FLUOXETINE HYDROCHLORIDE
ANDA #077849		 SUPPL-8 FLUOXETINE HYDROCHLORIDE LANNETT CO INC Labeling Approval
07/18/2014 VENLAFAXINE HYDROCHLORIDE
ANDA #078932		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE ALEMBIC PHARMS LTD Labeling Approval
07/18/2014 SELFEMRA
ANDA #200151		 SUPPL-1 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
07/18/2014 BUPROPION HYDROCHLORIDE
ANDA #201331		 SUPPL-1 BUPROPION HYDROCHLORIDE WOCKHARDT LTD Manufacturing (CMC) Approval
07/18/2014 FLUOXETINE HYDROCHLORIDE
NDA #202133		 SUPPL-3 FLUOXETINE HYDROCHLORIDE TWI PHARMS Labeling Approval
07/18/2014 TRAZODONE HYDROCHLORIDE
ANDA #202180		 SUPPL-3 TRAZODONE HYDROCHLORIDE TORRENT Labeling Approval
07/18/2014 ETOMIDATE
ANDA #202360		 ORIG-1 ETOMIDATE ZYDUS PHARMS Approval
07/18/2014 MESNA
ANDA #203364		 ORIG-1 MESNA RISING Approval
07/18/2014 TOPICORT
NDA #204141		 SUPPL-1 DESOXIMETASONE SUN PHARMA CANADA Manufacturing (CMC) Approval
07/18/2014 FETZIMA
NDA #204168		 SUPPL-2 LEVOMILNACIPRAN HYDROCHLORIDE ABBVIE Labeling Approval
07/18/2014 DESVENLAFAXINE
NDA #205208		 SUPPL-1 DESVENLAFAXINE FUMARATE TEVA PHARMS USA Labeling Approval
07/18/2014 DESVENLAFAXINE
NDA #205583		 SUPPL-1 DESVENLAFAXINE FUMARATE SUN PHARM Labeling Approval
07/18/2014 DESVENLAFAXINE
NDA #205583		 SUPPL-3 DESVENLAFAXINE FUMARATE SUN PHARM Labeling Approval
07/18/2014 ATROPINE SULFATE
NDA #206289		 ORIG-1 ATROPINE SULFATE RISING Type 7 - Drug Already Marketed without Approved NDA Approval
07/19/2014 METOPROLOL TARTRATE
ANDA #077739		 SUPPL-8 METOPROLOL TARTRATE AUROBINDO PHARMA Manufacturing (CMC) Approval
07/19/2014 LETROZOLE
ANDA #090934		 SUPPL-1 LETROZOLE ACCORD HLTHCARE Manufacturing (CMC) Approval
07/20/2014 FLOMAX
NDA #020579		 SUPPL-28 TAMSULOSIN HYDROCHLORIDE SANOFI Labeling Approval
07/21/2014 FIORINAL
NDA #017534		 SUPPL-72 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
07/21/2014 QVAR 40
NDA #020911		 SUPPL-25 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Labeling Approval
07/21/2014 QVAR 80
NDA #020911		 SUPPL-25 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Labeling Approval
07/21/2014 METRONIDAZOLE
ANDA #070027		 SUPPL-41 METRONIDAZOLE TEVA PHARMS USA Labeling Approval
07/21/2014 METRONIDAZOLE
ANDA #070033		 SUPPL-41 METRONIDAZOLE PLIVA Labeling Approval
07/21/2014 MORPHINE SULFATE
ANDA #074769		 SUPPL-19 MORPHINE SULFATE RHODES PHARMS Labeling Approval
07/21/2014 MORPHINE SULFATE
ANDA #074862		 SUPPL-19 MORPHINE SULFATE RHODES PHARMS Labeling Approval
07/21/2014 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #202940		 ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE PHARM ASSOC Approval
07/21/2014 PENNSAID
NDA #204623		 SUPPL-1 DICLOFENAC SODIUM HORIZON Manufacturing (CMC) Approval
07/22/2014 SOLU-CORTEF
NDA #009866		 SUPPL-101 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/22/2014 SOLU-MEDROL
NDA #011856		 SUPPL-121 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/22/2014 CYTOXAN
NDA #012142		 SUPPL-114 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/22/2014 CYTOXAN (LYOPHILIZED)
NDA #012142		 SUPPL-114 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/22/2014 LYOPHILIZED CYTOXAN
NDA #012142		 SUPPL-114 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
07/22/2014 LOTENSIN HCT
NDA #020033		 SUPPL-48 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Manufacturing (CMC) Approval
07/22/2014 CLARITIN HIVES RELIEF REDITAB
NDA #020704		 SUPPL-27 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/22/2014 CLARITIN REDITABS
NDA #020704		 SUPPL-27 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/22/2014 TEVETEN
NDA #020738		 SUPPL-29 EPROSARTAN MESYLATE ABBVIE Labeling Approval
07/22/2014 XELODA
NDA #020896		 SUPPL-33 CAPECITABINE CHEPLAPHARM Manufacturing (CMC) Approval
07/22/2014 TEVETEN HCT
NDA #021268		 SUPPL-19 EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE ABBVIE Labeling Approval
07/22/2014 PROHANCE MULTIPACK
NDA #021489		 SUPPL-4 GADOTERIDOL BRACCO Labeling Approval
07/22/2014 DESONATE
NDA #021844		 SUPPL-8 DESONIDE LEO PHARMA AS Labeling Approval
07/22/2014 CLARITIN REDITABS
NDA #021993		 SUPPL-12 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/22/2014 TACROLIMUS
ANDA #090687		 ORIG-1 TACROLIMUS STRIDES PHARMA Approval
07/22/2014 ZOLEDRONIC ACID
ANDA #204138		 ORIG-1 ZOLEDRONIC ACID SUN PHARMA GLOBAL Tentative Approval
07/22/2014 OTEZLA
NDA #205437		 SUPPL-1 APREMILAST AMGEN INC Manufacturing (CMC) Approval
07/22/2014 RYANODEX
NDA #205579		 ORIG-1 DANTROLENE SODIUM EAGLE PHARMS Type 3 - New Dosage Form Approval
07/23/2014 TERAZOL 7
NDA #019579		 SUPPL-37 TERCONAZOLE JANSSEN PHARMS Labeling Approval
07/23/2014 TERAZOL 3
NDA #019641		 SUPPL-30 TERCONAZOLE JANSSEN PHARMS Labeling Approval
07/23/2014 CARDENE
NDA #019734		 SUPPL-23 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/23/2014 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-23 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/23/2014 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-23 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/23/2014 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-23 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/23/2014 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-23 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/23/2014 TERAZOL 3
NDA #019964		 SUPPL-32 TERCONAZOLE JANSSEN PHARMS Labeling Approval
07/23/2014 METHADOSE
ANDA #040050		 SUPPL-16 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/23/2014 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-12 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/23/2014 FENTANYL-100
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-12
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-25
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-37
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-50
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-62
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-75
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 FENTANYL-87
ANDA #077449		 SUPPL-10 FENTANYL DIFGEN PHARMS Labeling Approval
07/23/2014 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-7 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC Labeling Approval
07/23/2014 EDARBI
NDA #200796		 SUPPL-6 AZILSARTAN KAMEDOXOMIL AZURITY Labeling Approval
07/23/2014 EDARBYCLOR
NDA #202331		 SUPPL-6 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE AZURITY Labeling Approval
07/23/2014 TESTOSTERONE
NDA #202763		 SUPPL-1 TESTOSTERONE ANI PHARMS Labeling Approval
07/23/2014 HYDROCHLOROTHIAZIDE
ANDA #203018		 ORIG-1 HYDROCHLOROTHIAZIDE SCIEGEN PHARMS Approval
07/23/2014 FLONASE ALLERGY RELIEF
NDA #205434		 ORIG-1 FLUTICASONE PROPIONATE HALEON US HOLDINGS Type 8 - Partial Rx to OTC Switch Approval
07/23/2014 TARGINIQ
NDA #205777		 ORIG-1 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Type 4 - New Combination Approval
07/23/2014 ZYDELIG
NDA #205858		 ORIG-1 IDELALISIB GILEAD SCIENCES INC Type 1 - New Molecular Entity Approval
07/23/2014 ZYDELIG
NDA #206545		 ORIG-1 IDELALISIB GILEAD SCIENCES INC Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
07/24/2014 CRIXIVAN
NDA #020685		 SUPPL-76 INDINAVIR SULFATE MERCK SHARP DOHME Labeling Approval
07/24/2014 ADDERALL XR 10
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 ADDERALL XR 15
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 ADDERALL XR 20
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 ADDERALL XR 25
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 ADDERALL XR 30
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 ADDERALL XR 5
NDA #021303		 SUPPL-27 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/24/2014 FORTICAL
NDA #021406		 SUPPL-23 CALCITONIN SALMON RECOMBINANT UPSHER SMITH LABS Manufacturing (CMC) Approval
07/24/2014 CAPITAL AND CODEINE
ANDA #086024		 SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE VALEANT PHARMS LLC Labeling Approval
07/24/2014 CAPITAL AND CODEINE
ANDA #086024		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE VALEANT PHARMS LLC Labeling Approval
07/24/2014 ICLUSIG
NDA #203469		 SUPPL-9 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
07/25/2014 MESTINON
NDA #011665		 SUPPL-20 PYRIDOSTIGMINE BROMIDE BAUSCH Manufacturing (CMC) Approval
07/25/2014 HABITROL
NDA #020076		 SUPPL-36 NICOTINE DR REDDYS LABS SA Labeling Approval
07/25/2014 ADRENACLICK
NDA #020800		 SUPPL-27 EPINEPHRINE IMPAX Labeling Approval
07/25/2014 TWINJECT
NDA #020800		 SUPPL-27 EPINEPHRINE IMPAX Labeling Approval
07/25/2014 APOKYN
NDA #021264		 SUPPL-10 APOMORPHINE HYDROCHLORIDE MDD US Labeling Approval
07/25/2014 ALINIA
NDA #021498		 SUPPL-6 NITAZOXANIDE ROMARK Manufacturing (CMC) Approval
07/25/2014 PREVANTICS MAXI SWABSTICK
NDA #021524		 SUPPL-15 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
07/25/2014 PREVANTICS SWAB
NDA #021524		 SUPPL-15 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
07/25/2014 PREVANTICS SWABSTICK
NDA #021524		 SUPPL-15 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
07/25/2014 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-18 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/25/2014 CLARITIN
NDA #021891		 SUPPL-18 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/25/2014 LASTACAFT
NDA #022134		 SUPPL-3 ALCAFTADINE ABBVIE Manufacturing (CMC) Approval
07/25/2014 PRADAXA
NDA #022512		 SUPPL-22 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/25/2014 AZACTAM IN PLASTIC CONTAINER
NDA #050632		 SUPPL-17 AZTREONAM BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
07/25/2014 BIAXIN
NDA #050662		 SUPPL-55 CLARITHROMYCIN ABBVIE Labeling Approval
07/25/2014 BIAXIN
NDA #050698		 SUPPL-35 CLARITHROMYCIN ABBVIE Labeling Approval
07/25/2014 BIAXIN XL
NDA #050775		 SUPPL-23 CLARITHROMYCIN ABBVIE Labeling Approval
07/25/2014 JAKAFI
NDA #202192		 SUPPL-6 RUXOLITINIB PHOSPHATE INCYTE CORP Efficacy Approval
07/25/2014 ACTICLATE
NDA #205931		 ORIG-1 DOXYCYCLINE HYCLATE CHARTWELL RX Type 5 - New Formulation or New Manufacturer Approval
07/28/2014 TOFRANIL-PM
NDA #017090		 SUPPL-78 IMIPRAMINE PAMOATE SPECGX LLC Labeling Approval
07/28/2014 MINIPRESS
NDA #017442		 SUPPL-42 PRAZOSIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
07/28/2014 PAMELOR
NDA #018012		 SUPPL-31 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/28/2014 PAMELOR
NDA #018013		 SUPPL-63 NORTRIPTYLINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/28/2014 CARDURA
NDA #019668		 SUPPL-27 DOXAZOSIN MESYLATE VIATRIS Manufacturing (CMC) Approval
07/28/2014 NORVASC
NDA #019787		 SUPPL-58 AMLODIPINE BESYLATE VIATRIS Manufacturing (CMC) Approval
07/28/2014 TECHNESCAN MAG3
NDA #019882		 SUPPL-10 TECHNETIUM TC-99M MERTIATIDE KIT CURIUM Manufacturing (CMC) Approval
07/28/2014 ANAFRANIL
NDA #019906		 SUPPL-39 CLOMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
07/28/2014 DIFLUCAN
NDA #019949		 SUPPL-59 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
07/28/2014 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-63 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
07/28/2014 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-63 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
07/28/2014 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-63 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
07/28/2014 DIFLUCAN
NDA #020090		 SUPPL-43 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
07/28/2014 AROMASIN
NDA #020753		 SUPPL-17 EXEMESTANE PFIZER Manufacturing (CMC) Approval
07/28/2014 DETROL
NDA #020771		 SUPPL-29 TOLTERODINE TARTRATE UPJOHN Manufacturing (CMC) Approval
07/28/2014 CELEBREX
NDA #020998		 SUPPL-45 CELECOXIB UPJOHN Manufacturing (CMC) Approval
07/28/2014 ZYVOX
NDA #021130		 SUPPL-33 LINEZOLID PFIZER Manufacturing (CMC) Approval
07/28/2014 ZYVOX
NDA #021131		 SUPPL-27 LINEZOLID PFIZER Manufacturing (CMC) Approval
07/28/2014 ZYVOX
NDA #021132		 SUPPL-32 LINEZOLID PFIZER Manufacturing (CMC) Approval
07/28/2014 DETROL LA
NDA #021228		 SUPPL-22 TOLTERODINE TARTRATE UPJOHN Manufacturing (CMC) Approval
07/28/2014 CARDURA XL
NDA #021269		 SUPPL-16 DOXAZOSIN MESYLATE VIATRIS Manufacturing (CMC) Approval
07/28/2014 CADUET
NDA #021540		 SUPPL-35 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Manufacturing (CMC) Approval
07/28/2014 TACLONEX
NDA #021852		 SUPPL-16 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
07/28/2014 CHANTIX
NDA #021928		 SUPPL-35 VARENICLINE TARTRATE PF PRISM CV Manufacturing (CMC) Approval
07/28/2014 TACLONEX
NDA #022185		 SUPPL-20 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Labeling Approval
07/28/2014 TACLONEX
NDA #022185		 SUPPL-20 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Labeling Approval
07/28/2014 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #070184		 SUPPL-61 METOCLOPRAMIDE HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
07/28/2014 AMANTADINE HYDROCHLORIDE
ANDA #070589		 SUPPL-44 AMANTADINE HYDROCHLORIDE UPSHER SMITH LABS Manufacturing (CMC) Approval
07/28/2014 EXEMESTANE
ANDA #200898		 ORIG-1 EXEMESTANE EIRGEN Approval
07/28/2014 VASCEPA
NDA #202057		 SUPPL-7 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
07/28/2014 KORLYM
NDA #202107		 SUPPL-3 MIFEPRISTONE CORCEPT THERAP Manufacturing (CMC) Approval
07/28/2014 VICTRELIS
NDA #202258		 SUPPL-15 BOCEPREVIR MERCK SHARP DOHME Labeling Approval
07/28/2014 OTEZLA
NDA #205437		 SUPPL-2 APREMILAST AMGEN INC Manufacturing (CMC) Approval
07/28/2014 IMBRUVICA
NDA #205552		 SUPPL-1 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
07/29/2014 NATRECOR
NDA #020920		 SUPPL-34 NESIRITIDE SCIOS LLC Manufacturing (CMC) Approval
07/29/2014 PRANDIMET
NDA #022386		 SUPPL-13 METFORMIN HYDROCHLORIDE; REPAGLINIDE NOVO NORDISK INC Manufacturing (CMC) Approval
07/29/2014 VIOKACE
BLA #022542		 SUPPL-2 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIOKACE Approval
07/29/2014 VIOKACE
BLA #022542		 SUPPL-6 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIOKACE Approval
07/29/2014 SERTRALINE HYDROCHLORIDE
ANDA #078626		 SUPPL-2 SERTRALINE HYDROCHLORIDE QUAGEN Manufacturing (CMC) Approval
07/29/2014 EYLEA
BLA #125387		 SUPPL-37 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
07/29/2014 KORLYM
NDA #202107		 SUPPL-4 MIFEPRISTONE CORCEPT THERAP Manufacturing (CMC) Approval
07/29/2014 KALYDECO
NDA #203188		 SUPPL-11 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
07/29/2014 EPINEPHRINE
NDA #205029		 ORIG-1 EPINEPHRINE BPI LABS Type 7 - Drug Already Marketed without Approved NDA Approval
07/30/2014 QUELICIN
NDA #008845		 SUPPL-70 SUCCINYLCHOLINE CHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/30/2014 QUELICIN PRESERVATIVE FREE
NDA #008845		 SUPPL-70 SUCCINYLCHOLINE CHLORIDE HOSPIRA Manufacturing (CMC) Approval
07/30/2014 HUMATROPE
BLA #019640		 SUPPL-92 SOMATROPIN LILLY Approval
07/30/2014 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-25 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Manufacturing (CMC) Approval
07/30/2014 CANASA
NDA #021252		 SUPPL-21 MESALAMINE ABBVIE Manufacturing (CMC) Approval
07/30/2014 DICLEGIS
NDA #021876		 SUPPL-4 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
07/30/2014 ABSORICA
NDA #021951		 SUPPL-1 ISOTRETINOIN SUN PHARM INDS INC Labeling Approval
07/30/2014 AMOXIL
NDA #050760		 SUPPL-16 AMOXICILLIN US ANTIBIOTICS Manufacturing (CMC) Approval
07/30/2014 JENTADUETO
NDA #201281		 SUPPL-6 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Efficacy Approval
07/30/2014 ICLUSIG
NDA #203469		 SUPPL-10 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
07/31/2014 LOESTRIN FE 1/20
NDA #017354		 SUPPL-45 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
07/31/2014 ESTRADIOL
NDA #020538		 SUPPL-32 ESTRADIOL SANDOZ Labeling Approval
07/31/2014 VIVELLE-DOT
NDA #020538		 SUPPL-32 ESTRADIOL SANDOZ Labeling Approval
07/31/2014 HUMALOG
BLA #020563		 SUPPL-51 INSULIN LISPRO RECOMBINANT LILLY Approval
07/31/2014 HUMALOG KWIKPEN
BLA #020563		 SUPPL-51 INSULIN LISPRO RECOMBINANT LILLY Approval
07/31/2014 HUMALOG PEN
BLA #020563		 SUPPL-51 INSULIN LISPRO RECOMBINANT LILLY Approval
07/31/2014 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-51 INSULIN LISPRO RECOMBINANT LILLY Approval
07/31/2014 HECTOROL
NDA #021027		 SUPPL-29 DOXERCALCIFEROL SANOFI Manufacturing (CMC) Approval
07/31/2014 SOMAVERT
BLA #021106		 SUPPL-44 PEGVISOMANT PHARMACIA Approval
07/31/2014 FORTESTA
NDA #021463		 SUPPL-15 TESTOSTERONE ENDO OPERATIONS REMS Approval
07/31/2014 ZELAPAR
NDA #021479		 SUPPL-5 SELEGILINE HYDROCHLORIDE BAUSCH Labeling Approval
07/31/2014 MEGACE ES
NDA #021778		 SUPPL-17 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
07/31/2014 VICTOZA
NDA #022341		 SUPPL-21 LIRAGLUTIDE NOVO NORDISK INC REMS Approval
07/31/2014 ZANOSAR
NDA #050577		 SUPPL-38 STREPTOZOCIN TEVA PHARMS USA Manufacturing (CMC) Approval
07/31/2014 PEGINTRON
BLA #103949		 SUPPL-5295 PEGINTERFERON ALFA-2B SCHERING Approval
07/31/2014 SYLATRON
BLA #103949		 SUPPL-5295 PEGINTERFERON ALFA-2B SCHERING Approval
07/31/2014 GILOTRIF
NDA #201292		 SUPPL-3 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
07/31/2014 FARXIGA
NDA #202293		 SUPPL-1 DAPAGLIFLOZIN ASTRAZENECA AB Manufacturing (CMC) Approval
07/31/2014 STRIVERDI RESPIMAT
NDA #203108		 ORIG-1 OLODATEROL HYDROCHLORIDE BOEHRINGER INGELHEIM Type 1 - New Molecular Entity Approval
07/31/2014 ADRENALIN
NDA #204200		 SUPPL-1 EPINEPHRINE PH HEALTH Manufacturing (CMC) Approval
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