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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 2015

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 April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2015 CYKLOKAPRON
NDA #019281		 SUPPL-35 TRANEXAMIC ACID PFIZER Manufacturing (CMC) Approval
06/01/2015 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-65 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
06/01/2015 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950		 SUPPL-65 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
06/01/2015 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950		 SUPPL-65 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
06/01/2015 GLIADEL
NDA #020637		 SUPPL-28 CARMUSTINE AZURITY Manufacturing (CMC) Approval
06/01/2015 YASMIN
NDA #021098		 SUPPL-23 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Labeling Approval
06/01/2015 CRESTOR
NDA #021366		 SUPPL-32 ROSUVASTATIN CALCIUM IPR Labeling Approval
06/01/2015 YAZ
NDA #021676		 SUPPL-14 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Labeling Approval
06/01/2015 OMEPRAZOLE
NDA #022032		 SUPPL-28 OMEPRAZOLE DEXCEL PHARMA Manufacturing (CMC) Approval
06/01/2015 SOMATULINE DEPOT
NDA #022074		 SUPPL-12 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
06/01/2015 SOMATULINE DEPOT
NDA #022074		 SUPPL-13 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
06/01/2015 METAXALONE
NDA #022503		 ORIG-1 METAXALONE PRIMUS PHARMS Type 3 - New Dosage Form Approval
06/01/2015 BEYAZ
NDA #022532		 SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BAYER HLTHCARE Labeling Approval
06/01/2015 SAFYRAL
NDA #022574		 SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BAYER HLTHCARE Labeling Approval
06/01/2015 METHADOSE
ANDA #040050		 SUPPL-20 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/01/2015 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-16 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/01/2015 AMPICILLIN AND SULBACTAM
ANDA #065188		 SUPPL-11 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA Labeling Approval
06/01/2015 AMPICILLIN AND SULBACTAM
ANDA #065188		 SUPPL-12 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA Labeling Approval
06/01/2015 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-10 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
06/01/2015 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070947		 SUPPL-29 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE RISING Labeling Approval
06/01/2015 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075618		 SUPPL-23 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE HIKMA INTL PHARMS Labeling Approval
06/01/2015 ANAGRELIDE HYDROCHLORIDE
ANDA #076683		 SUPPL-6 ANAGRELIDE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/01/2015 ANAGRELIDE HYDROCHLORIDE
ANDA #076683		 SUPPL-7 ANAGRELIDE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/01/2015 ZOLPIDEM TARTRATE
ANDA #077214		 SUPPL-6 ZOLPIDEM TARTRATE ACME LABS Labeling Approval
06/01/2015 MITOXANTRONE HYDROCHLORIDE
ANDA #077496		 SUPPL-6 MITOXANTRONE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/01/2015 ALFUZOSIN HYDROCHLORIDE
ANDA #079057		 SUPPL-9 ALFUZOSIN HYDROCHLORIDE SUN PHARM Labeling Approval
06/01/2015 ADENOSINE
ANDA #090010		 SUPPL-1 ADENOSINE AM REGENT Labeling Approval
06/01/2015 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-10 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
06/01/2015 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201087		 ORIG-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN STRIDES PHARMA Approval
06/01/2015 GADAVIST
NDA #201277		 SUPPL-9 GADOBUTROL BAYER HLTHCARE Manufacturing (CMC) Approval
06/01/2015 OXYCODONE HYDROCHLORIDE
ANDA #204979		 ORIG-1 OXYCODONE HYDROCHLORIDE ANI PHARMS Approval
06/02/2015 HYCAMTIN
NDA #020671		 SUPPL-21 TOPOTECAN HYDROCHLORIDE SANDOZ Labeling Approval
06/02/2015 EXALGO
NDA #021217		 SUPPL-9 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/02/2015 RITALIN LA
NDA #021284		 SUPPL-26 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
06/02/2015 TRAZODONE HYDROCHLORIDE
ANDA #071196		 SUPPL-62 TRAZODONE HYDROCHLORIDE APOTEX INC Labeling Approval
06/02/2015 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #073118		 SUPPL-26 METOCLOPRAMIDE HYDROCHLORIDE HOSPIRA Labeling Approval
06/02/2015 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #073118		 SUPPL-28 METOCLOPRAMIDE HYDROCHLORIDE HOSPIRA Labeling Approval
06/02/2015 ETODOLAC
ANDA #074903		 SUPPL-23 ETODOLAC SANDOZ Labeling Approval
06/02/2015 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #075768		 SUPPL-16 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE MYLAN Labeling Approval
06/02/2015 ANAGRELIDE HYDROCHLORIDE
ANDA #076468		 SUPPL-12 ANAGRELIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
06/02/2015 ANAGRELIDE HYDROCHLORIDE
ANDA #076468		 SUPPL-14 ANAGRELIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
06/02/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #078905		 SUPPL-1 GLIPIZIDE; METFORMIN HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
06/02/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #078905		 SUPPL-2 GLIPIZIDE; METFORMIN HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
06/02/2015 SUMATRIPTAN SUCCINATE
ANDA #079242		 SUPPL-2 SUMATRIPTAN SUCCINATE FRESENIUS KABI USA Labeling Approval
06/02/2015 SUMATRIPTAN SUCCINATE
ANDA #079242		 SUPPL-3 SUMATRIPTAN SUCCINATE FRESENIUS KABI USA Labeling Approval
06/02/2015 NICARDIPINE HYDROCHLORIDE
ANDA #090534		 SUPPL-3 NICARDIPINE HYDROCHLORIDE AM REGENT Labeling Approval
06/02/2015 NICARDIPINE HYDROCHLORIDE
ANDA #090534		 SUPPL-4 NICARDIPINE HYDROCHLORIDE AM REGENT Labeling Approval
06/02/2015 GEMCITABINE HYDROCHLORIDE
ANDA #091594		 SUPPL-6 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
06/02/2015 GEMCITABINE HYDROCHLORIDE
ANDA #091594		 SUPPL-7 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
06/02/2015 PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
ANDA #201049		 SUPPL-1 GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE SANDOZ Labeling Approval
06/02/2015 GUANFACINE HYDROCHLORIDE
ANDA #201382		 ORIG-1 GUANFACINE HYDROCHLORIDE TEVA PHARMS USA Approval
06/02/2015 GUANFACINE HYDROCHLORIDE
ANDA #201408		 ORIG-1 GUANFACINE HYDROCHLORIDE TWI PHARMS Approval
06/02/2015 GUANFACINE HYDROCHLORIDE
ANDA #202578		 ORIG-1 GUANFACINE HYDROCHLORIDE MYLAN Approval
06/02/2015 LISINOPRIL
ANDA #203508		 SUPPL-2 LISINOPRIL INVAGEN PHARMS Labeling Approval
06/02/2015 LISINOPRIL
ANDA #203508		 SUPPL-3 LISINOPRIL INVAGEN PHARMS Labeling Approval
06/02/2015 CELECOXIB
ANDA #204197		 ORIG-1 CELECOXIB APOTEX Approval
06/02/2015 NEXIUM 24HR
NDA #204655		 SUPPL-2 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
06/02/2015 VARITHENA
NDA #205098		 SUPPL-8 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
06/03/2015 XENAZINE
NDA #021894		 SUPPL-10 TETRABENAZINE BAUSCH Labeling Approval
06/03/2015 BUDESONIDE
ANDA #077519		 SUPPL-13 BUDESONIDE TEVA PHARMS Manufacturing (CMC) Approval
06/03/2015 LINEZOLID
ANDA #200068		 ORIG-1 LINEZOLID HIKMA Approval
06/03/2015 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200797		 ORIG-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Approval
06/03/2015 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201593		 ORIG-1 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TORRENT Approval
06/03/2015 GUANFACINE HYDROCHLORIDE
ANDA #202568		 ORIG-1 GUANFACINE HYDROCHLORIDE SANDOZ Approval
06/03/2015 MORPHINE SULFATE
ANDA #202718		 SUPPL-1 MORPHINE SULFATE TEVA PHARMS USA Manufacturing (CMC) Approval
06/03/2015 ZOLPIDEM TARTRATE
ANDA #204299		 ORIG-1 ZOLPIDEM TARTRATE NOVEL LABS INC Approval
06/04/2015 CEREBYX
NDA #020450		 SUPPL-28 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
06/04/2015 MEPRON
NDA #020500		 SUPPL-15 ATOVAQUONE GLAXOSMITHKLINE LLC Labeling Approval
06/04/2015 ARRANON
NDA #021877		 SUPPL-6 NELARABINE SANDOZ Manufacturing (CMC) Approval
06/04/2015 AZOR
NDA #022100		 SUPPL-28 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
06/04/2015 DORYX
NDA #050795		 SUPPL-18 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
06/04/2015 DORYX MPC
NDA #050795		 SUPPL-18 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-48 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-51 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-53 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-54 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-55 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-56 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 LISINOPRIL
ANDA #076063		 SUPPL-57 LISINOPRIL HIKMA INTL PHARMS Labeling Approval
06/04/2015 BETAMETHASONE DIPROPIONATE
ANDA #076603		 SUPPL-17 BETAMETHASONE DIPROPIONATE ANDA REPOSITORY Labeling Approval
06/04/2015 BETAMETHASONE DIPROPIONATE
ANDA #076753		 SUPPL-7 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
06/04/2015 SERTRALINE HYDROCHLORIDE
ANDA #076882		 SUPPL-16 SERTRALINE HYDROCHLORIDE VIWIT PHARM Labeling Approval
06/04/2015 GEMFIBROZIL
ANDA #079239		 SUPPL-9 GEMFIBROZIL SUN PHARM INDS INC Labeling Approval
06/04/2015 GEMFIBROZIL
ANDA #079239		 SUPPL-10 GEMFIBROZIL SUN PHARM INDS INC Labeling Approval
06/04/2015 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-11 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC Labeling Approval
06/04/2015 LEVETIRACETAM
ANDA #201157		 ORIG-1 LEVETIRACETAM PHARM ASSOC Approval
06/04/2015 LINCOMYCIN HYDROCHLORIDE
ANDA #201746		 ORIG-1 LINCOMYCIN HYDROCHLORIDE XGEN PHARMS Approval
06/04/2015 TEMAZEPAM
ANDA #201781		 ORIG-1 TEMAZEPAM PRINSTON INC Approval
06/04/2015 REVATIO
NDA #203109		 SUPPL-8 SILDENAFIL CITRATE VIATRIS Manufacturing (CMC) Approval
06/04/2015 ZUBSOLV
NDA #204242		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC Manufacturing (CMC) Approval
06/05/2015 METHADONE HYDROCHLORIDE
NDA #006383		 SUPPL-16 METHADONE HYDROCHLORIDE MALLINCKRODT INC Manufacturing (CMC) Approval
06/05/2015 FUROSEMIDE
NDA #018569		 SUPPL-62 FUROSEMIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
06/05/2015 GOLYTELY
NDA #019011		 SUPPL-26 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS BRAINTREE Manufacturing (CMC) Approval
06/05/2015 FLUOCINONIDE
NDA #019117		 SUPPL-35 FLUOCINONIDE TARO Manufacturing (CMC) Approval
06/05/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/05/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/05/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/05/2015 ZYVOX
NDA #021130		 SUPPL-35 LINEZOLID PFIZER Labeling Approval
06/05/2015 ZYVOX
NDA #021131		 SUPPL-29 LINEZOLID PFIZER Labeling Approval
06/05/2015 ZYVOX
NDA #021132		 SUPPL-34 LINEZOLID PFIZER Labeling Approval
06/05/2015 ORFADIN
NDA #021232		 SUPPL-16 NITISINONE SWEDISH ORPHAN Manufacturing (CMC) Approval
06/05/2015 JENLOGA
NDA #022331		 SUPPL-15 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Labeling Approval
06/05/2015 KAPVAY
NDA #022331		 SUPPL-15 CLONIDINE HYDROCHLORIDE CONCORDIA PHARMS INC Labeling Approval
06/05/2015 INDOMETHACIN
NDA #022536		 SUPPL-4 INDOMETHACIN FRESENIUS KABI USA Manufacturing (CMC) Approval
06/05/2015 TRAZODONE HYDROCHLORIDE
ANDA #072193		 SUPPL-48 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
06/05/2015 EPTIFIBATIDE
ANDA #091555		 ORIG-1 EPTIFIBATIDE TEVA PHARMS USA Approval
06/05/2015 LEVONORGESTREL
ANDA #202246		 ORIG-1 LEVONORGESTREL ALVOGEN Approval
06/05/2015 FETZIMA
NDA #204168		 SUPPL-3 LEVOMILNACIPRAN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/05/2015 DONEPEZIL HYDROCHLORIDE
ANDA #204293		 ORIG-1 DONEPEZIL HYDROCHLORIDE SUN PHARM Approval
06/06/2015 DOXYCYCLINE
ANDA #201678		 SUPPL-2 DOXYCYCLINE LUPIN LTD Labeling Approval
06/08/2015 ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
NDA #020786		 SUPPL-33 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE CHATTEM SANOFI Efficacy Approval
06/08/2015 COMBIPATCH
NDA #020870		 SUPPL-20 ESTRADIOL; NORETHINDRONE ACETATE NOVEN PHARMS INC Manufacturing (CMC) Approval
06/08/2015 CARDURA XL
NDA #021269		 SUPPL-17 DOXAZOSIN MESYLATE VIATRIS Labeling Approval
06/08/2015 DURAPREP
NDA #021586		 SUPPL-5 IODINE POVACRYLEX; ISOPROPYL ALCOHOL 3M Labeling Approval
06/08/2015 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
NDA #021704		 SUPPL-17 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE CHATTEM SANOFI Efficacy Approval
06/08/2015 EGRIFTA
BLA #022505		 SUPPL-7 TESAMORELIN ACETATE THERATECHNOLOGIES Approval
06/08/2015 ATENOLOL
ANDA #074056		 SUPPL-38 ATENOLOL TEVA Labeling Approval
06/08/2015 MICONAZOLE 7
ANDA #074164		 SUPPL-27 MICONAZOLE NITRATE P AND L Manufacturing (CMC) Approval
06/08/2015 BALSALAZIDE DISODIUM
ANDA #077883		 SUPPL-2 BALSALAZIDE DISODIUM APOTEX INC Labeling Approval
06/08/2015 PROLIA
BLA #125320		 SUPPL-168 DENOSUMAB AMGEN Approval
06/08/2015 XGEVA
BLA #125320		 SUPPL-168 DENOSUMAB AMGEN Approval
06/08/2015 CONTRAVE
NDA #200063		 SUPPL-2 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Manufacturing (CMC) Approval
06/08/2015 STRIBILD
NDA #203100		 SUPPL-15 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
06/08/2015 MEGESTROL ACETATE
ANDA #203139		 SUPPL-2 MEGESTROL ACETATE TWI PHARMS Labeling Approval
06/08/2015 INVOKAMET
NDA #204353		 SUPPL-4 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Manufacturing (CMC) Approval
06/08/2015 LITHIUM CARBONATE
ANDA #204445		 ORIG-1 LITHIUM CARBONATE ALEMBIC Approval
06/09/2015 PREMARIN
NDA #004782		 SUPPL-172 ESTROGENS, CONJUGATED WYETH PHARMS Manufacturing (CMC) Approval
06/09/2015 CHLORAPREP ONE-STEP
NDA #020832		 SUPPL-35 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
06/09/2015 CHLORAPREP ONE-STEP FREPP
NDA #020832		 SUPPL-35 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
06/09/2015 CHLORAPREP WITH TINT
NDA #020832		 SUPPL-35 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL BECTON DICKINSON CO Manufacturing (CMC) Approval
06/09/2015 RENAGEL
NDA #021179		 SUPPL-31 SEVELAMER HYDROCHLORIDE GENZYME Manufacturing (CMC) Approval
06/09/2015 ZOMETA
NDA #021223		 SUPPL-32 ZOLEDRONIC ACID NOVARTIS Labeling Approval
06/09/2015 INVEGA SUSTENNA
NDA #022264		 SUPPL-18 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
06/09/2015 CARISOPRODOL
ANDA #040124		 SUPPL-20 CARISOPRODOL HIKMA INTL PHARMS Labeling Approval
06/09/2015 MOXATAG
NDA #050813		 SUPPL-3 AMOXICILLIN PRAGMA Labeling Approval
06/09/2015 TRIMETHOBENZAMIDE HYDROCHLORIDE
ANDA #076546		 SUPPL-7 TRIMETHOBENZAMIDE HYDROCHLORIDE LUPIN Labeling Approval
06/09/2015 SERTRALINE HYDROCHLORIDE
ANDA #077397		 SUPPL-9 SERTRALINE HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/09/2015 SERTRALINE HYDROCHLORIDE
ANDA #077397		 SUPPL-14 SERTRALINE HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/09/2015 CELECOXIB
ANDA #202240		 ORIG-2 CELECOXIB LUPIN LTD Approval
06/09/2015 METHOXSALEN
ANDA #202603		 ORIG-1 METHOXSALEN ACTAVIS INC Approval
06/09/2015 SUBSYS
NDA #202788		 SUPPL-13 FENTANYL BTCP PHARMA Manufacturing (CMC) Approval
06/09/2015 VALSARTAN
ANDA #204821		 ORIG-1 VALSARTAN PRINSTON INC Approval
06/09/2015 CALCIPOTRIENE
ANDA #205772		 ORIG-1 CALCIPOTRIENE GLENMARK PHARMS Approval
06/09/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207488		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ABHAI LLC Approval
06/10/2015 ZEGERID OTC
NDA #022281		 SUPPL-8 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Labeling Approval
06/10/2015 ALBUTEROL SULFATE
ANDA #074454		 SUPPL-30 ALBUTEROL SULFATE COSETTE Labeling Approval
06/10/2015 LOSARTAN POTASSIUM
ANDA #078243		 SUPPL-3 LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Manufacturing (CMC) Approval
06/10/2015 LOSARTAN POTASSIUM
ANDA #078243		 SUPPL-19 LOSARTAN POTASSIUM ZYDUS PHARMS USA INC Labeling Approval
06/10/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090279		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE RUBICON Approval
06/10/2015 RIVASTIGMINE TARTRATE
ANDA #090879		 ORIG-1 RIVASTIGMINE TARTRATE ORBION PHARMS Approval
06/10/2015 BICALUTAMIDE
ANDA #091011		 ORIG-1 BICALUTAMIDE CHARTWELL RX Approval
06/10/2015 TEMOZOLOMIDE
ANDA #201742		 SUPPL-5 TEMOZOLOMIDE SUN PHARM Labeling Approval
06/10/2015 PHENYTOIN SODIUM
ANDA #204309		 ORIG-1 PHENYTOIN SODIUM AUROBINDO PHARMA Approval
06/11/2015 DEPO-PROVERA
NDA #012541		 SUPPL-83 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
06/11/2015 SAIZEN
BLA #019764		 SUPPL-62 SOMATROPIN EMD SERONO Approval
06/11/2015 IMITREX
NDA #020080		 SUPPL-48 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
06/11/2015 IMITREX STATDOSE
NDA #020080		 SUPPL-48 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
06/11/2015 HUMALOG
BLA #020563		 SUPPL-159 INSULIN LISPRO RECOMBINANT LILLY Approval
06/11/2015 HUMALOG KWIKPEN
BLA #020563		 SUPPL-159 INSULIN LISPRO RECOMBINANT LILLY Approval
06/11/2015 HUMALOG PEN
BLA #020563		 SUPPL-159 INSULIN LISPRO RECOMBINANT LILLY Approval
06/11/2015 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-159 INSULIN LISPRO RECOMBINANT LILLY Approval
06/11/2015 ELLIOTTS B SOLUTION
NDA #020577		 SUPPL-6 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE LUKARE MEDICAL LLC Manufacturing (CMC) Approval
06/11/2015 ALBENZA
NDA #020666		 SUPPL-9 ALBENDAZOLE IMPAX LABS INC Labeling Approval
06/11/2015 ESTROGEL
NDA #021166		 SUPPL-13 ESTRADIOL ASCEND THERAPS US Manufacturing (CMC) Approval
06/11/2015 M.V.I. ADULT
NDA #021625		 SUPPL-19 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
06/11/2015 OMEPRAZOLE
NDA #022032		 SUPPL-29 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
06/11/2015 ZEGERID OTC
NDA #022283		 SUPPL-1 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Labeling Approval
06/11/2015 PROMACTA
NDA #022291		 SUPPL-15 ELTROMBOPAG OLAMINE NOVARTIS Efficacy Approval
06/11/2015 ANDROGEL
NDA #022309		 SUPPL-13 TESTOSTERONE BESINS HLTHCARE Manufacturing (CMC) Approval
06/11/2015 APTIOM
NDA #022416		 SUPPL-2 ESLICARBAZEPINE ACETATE SUMITOMO PHARMA AM Manufacturing (CMC) Approval
06/11/2015 VIIBRYD
NDA #022567		 SUPPL-15 VILAZODONE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/11/2015 ATENOLOL AND CHLORTHALIDONE
ANDA #073665		 SUPPL-39 ATENOLOL; CHLORTHALIDONE WATSON LABS Labeling Approval
06/11/2015 FENTANYL-100
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-12
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-25
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-37
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-50
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-62
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 FENTANYL-75
ANDA #077154		 SUPPL-2 FENTANYL SPECGX LLC Manufacturing (CMC) Approval
06/11/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #078213		 SUPPL-8 PROPRANOLOL HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
06/11/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #078213		 SUPPL-9 PROPRANOLOL HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
06/11/2015 JEVTANA KIT
NDA #201023		 SUPPL-14 CABAZITAXEL SANOFI AVENTIS US Manufacturing (CMC) Approval
06/12/2015 LITHIUM CITRATE
NDA #018421		 SUPPL-29 LITHIUM CITRATE HIKMA Manufacturing (CMC) Approval
06/12/2015 SAIZEN
BLA #019764		 SUPPL-78 SOMATROPIN EMD SERONO Approval
06/12/2015 BIO-TROPIN
BLA #019774		 SUPPL-31 SOMATROPIN FERRING Approval
06/12/2015 ZOMACTON
BLA #019774		 SUPPL-31 SOMATROPIN FERRING Approval
06/12/2015 HUMALOG
BLA #020563		 SUPPL-163 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2015 HUMALOG KWIKPEN
BLA #020563		 SUPPL-163 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2015 HUMALOG PEN
BLA #020563		 SUPPL-163 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2015 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-163 INSULIN LISPRO RECOMBINANT LILLY Approval
06/12/2015 NORDITROPIN
BLA #021148		 SUPPL-28 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 NORDITROPIN
BLA #021148		 SUPPL-43 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-28 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-43 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-28 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-43 SOMATROPIN NOVO NORDISK INC Approval
06/12/2015 ZOMIG
NDA #021450		 SUPPL-8 ZOLMITRIPTAN AMNEAL Efficacy Approval
06/12/2015 FOCALIN XR
NDA #021802		 SUPPL-27 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
06/12/2015 JANUMET
NDA #022044		 SUPPL-33 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Manufacturing (CMC) Approval
06/12/2015 IMIPENEM AND CILASTATIN
ANDA #090825		 SUPPL-2 CILASTATIN SODIUM; IMIPENEM HOSPIRA INC Labeling Approval
06/12/2015 IMIPENEM AND CILASTATIN
ANDA #090825		 SUPPL-8 CILASTATIN SODIUM; IMIPENEM HOSPIRA INC Labeling Approval
06/12/2015 EPTIFIBATIDE
ANDA #090854		 ORIG-1 EPTIFIBATIDE TEVA PHARMS USA Approval
06/12/2015 CLINDAMYCIN PHOSPHATE AND TRETINOIN
ANDA #202564		 ORIG-1 CLINDAMYCIN PHOSPHATE; TRETINOIN ACTAVIS MID ATLANTIC Approval
06/12/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #203164		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Approval
06/12/2015 DESOXIMETASONE
ANDA #203234		 ORIG-1 DESOXIMETASONE SAPTALIS PHARMS Approval
06/12/2015 UCERIS
NDA #203634		 SUPPL-5 BUDESONIDE SALIX Manufacturing (CMC) Approval
06/12/2015 VELPHORO
NDA #205109		 SUPPL-2 FERRIC OXYHYDROXIDE VIFOR FRESENIUS Manufacturing (CMC) Approval
06/13/2015 CLINDAMYCIN PHOSPHATE
ANDA #062801		 SUPPL-30 CLINDAMYCIN PHOSPHATE ALMAJECT Labeling Approval
06/13/2015 NADOLOL
ANDA #074501		 SUPPL-6 NADOLOL SANDOZ Labeling Approval
06/13/2015 LISINOPRIL
ANDA #076071		 SUPPL-24 LISINOPRIL STRIDES PHARMA Labeling Approval
06/13/2015 LISINOPRIL
ANDA #076071		 SUPPL-25 LISINOPRIL STRIDES PHARMA Labeling Approval
06/13/2015 LISINOPRIL
ANDA #076071		 SUPPL-27 LISINOPRIL STRIDES PHARMA Labeling Approval
06/13/2015 LOSARTAN POTASSIUM
ANDA #077459		 SUPPL-9 LOSARTAN POTASSIUM HIKMA Labeling Approval
06/13/2015 ZONISAMIDE
ANDA #077651		 SUPPL-11 ZONISAMIDE GLENMARK PHARMS INC Labeling Approval
06/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732		 SUPPL-6 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM HIKMA Labeling Approval
06/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732		 SUPPL-7 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM HIKMA Labeling Approval
06/13/2015 ZONISAMIDE
ANDA #077869		 SUPPL-3 ZONISAMIDE INVAGEN PHARMS Labeling Approval
06/13/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #078022		 SUPPL-5 PROPRANOLOL HYDROCHLORIDE MYLAN Labeling Approval
06/13/2015 GRANISETRON HYDROCHLORIDE
ANDA #078258		 SUPPL-2 GRANISETRON HYDROCHLORIDE AMNEAL Labeling Approval
06/13/2015 GRANISETRON HYDROCHLORIDE
ANDA #078808		 SUPPL-12 GRANISETRON HYDROCHLORIDE SANDOZ Labeling Approval
06/13/2015 SYEDA
ANDA #090114		 SUPPL-5 DROSPIRENONE; ETHINYL ESTRADIOL XIROMED Labeling Approval
06/13/2015 PARICALCITOL
ANDA #090829		 SUPPL-2 PARICALCITOL TEVA PHARMS USA Labeling Approval
06/13/2015 NIFEDIPINE
ANDA #201071		 SUPPL-5 NIFEDIPINE RISING Labeling Approval
06/14/2015 FLUDARABINE PHOSPHATE
ANDA #076661		 SUPPL-14 FLUDARABINE PHOSPHATE SAGENT PHARMS INC Labeling Approval
06/14/2015 SUMATRIPTAN SUCCINATE
ANDA #076847		 SUPPL-2 SUMATRIPTAN SUCCINATE DR REDDYS LABS INC Labeling Approval
06/14/2015 SUMATRIPTAN SUCCINATE
ANDA #076847		 SUPPL-3 SUMATRIPTAN SUCCINATE DR REDDYS LABS INC Labeling Approval
06/14/2015 METRONIDAZOLE
ANDA #077547		 SUPPL-9 METRONIDAZOLE ENCUBE Labeling Approval
06/14/2015 DESOXIMETASONE
ANDA #078369		 SUPPL-3 DESOXIMETASONE FOUGERA PHARMS Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-16 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-20 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-21 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-20 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #079095		 SUPPL-21 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #202775		 SUPPL-4 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
06/14/2015 BUPROPION HYDROCHLORIDE
ANDA #202775		 SUPPL-5 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
06/14/2015 LEVETIRACETAM
ANDA #203059		 SUPPL-4 LEVETIRACETAM SUN PHARM Labeling Approval
06/14/2015 LEVETIRACETAM
ANDA #203059		 SUPPL-7 LEVETIRACETAM SUN PHARM Labeling Approval
06/14/2015 LEVETIRACETAM
ANDA #203059		 SUPPL-8 LEVETIRACETAM SUN PHARM Labeling Approval
06/14/2015 AMIKACIN SULFATE
ANDA #204040		 SUPPL-1 AMIKACIN SULFATE AVET LIFESCIENCES Labeling Approval
06/15/2015 REGLAN
NDA #017854		 SUPPL-61 METOCLOPRAMIDE HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
06/15/2015 CYSTAGON
NDA #020392		 SUPPL-13 CYSTEAMINE BITARTRATE MYLAN Manufacturing (CMC) Approval
06/15/2015 MAXALT
NDA #020864		 SUPPL-21 RIZATRIPTAN BENZOATE ORGANON LLC Manufacturing (CMC) Approval
06/15/2015 METADATE CD
NDA #021259		 SUPPL-28 METHYLPHENIDATE HYDROCHLORIDE AYTU BIOPHARMA Manufacturing (CMC) Approval
06/15/2015 NOXAFIL
NDA #022003		 SUPPL-15 POSACONAZOLE SCHERING Manufacturing (CMC) Approval
06/15/2015 TRAZODONE HYDROCHLORIDE
ANDA #072192		 SUPPL-46 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Labeling Approval
06/15/2015 GEMIFLOXACIN MESYLATE
ANDA #090466		 ORIG-1 GEMIFLOXACIN MESYLATE ORBION PHARMS Approval
06/15/2015 TRIUMEQ
NDA #205551		 SUPPL-1 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Manufacturing (CMC) Approval
06/16/2015 FIORICET W/ CODEINE
NDA #020232		 SUPPL-38 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
06/16/2015 LOTREL
NDA #020364		 SUPPL-59 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
06/16/2015 LANTUS
BLA #021081		 SUPPL-64 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
06/16/2015 LANTUS SOLOSTAR
BLA #021081		 SUPPL-64 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
06/16/2015 INVEGA SUSTENNA
NDA #022264		 SUPPL-17 PALIPERIDONE PALMITATE JANSSEN PHARMS Manufacturing (CMC) Approval
06/16/2015 DESONIDE
ANDA #074027		 SUPPL-3 DESONIDE COSETTE Manufacturing (CMC) Approval
06/16/2015 NEVIRAPINE
ANDA #077702		 SUPPL-9 NEVIRAPINE AUROBINDO Manufacturing (CMC) Approval
06/16/2015 SIMPONI
BLA #125289		 SUPPL-124 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
06/16/2015 ELIQUIS
NDA #202155		 SUPPL-10 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
06/16/2015 TECFIDERA
NDA #204063		 SUPPL-11 DIMETHYL FUMARATE BIOGEN INC Manufacturing (CMC) Approval
06/16/2015 SOTYLIZE
NDA #205108		 SUPPL-1 SOTALOL HYDROCHLORIDE AZURITY Manufacturing (CMC) Approval
06/16/2015 QUDEXY XR
NDA #205122		 SUPPL-2 TOPIRAMATE UPSHER SMITH LABS Manufacturing (CMC) Approval
06/16/2015 ASMANEX HFA
NDA #205641		 SUPPL-2 MOMETASONE FUROATE ORGANON LLC Labeling Approval
06/16/2015 OXYCODONE HYDROCHLORIDE
ANDA #206456		 ORIG-1 OXYCODONE HYDROCHLORIDE XTTRIUM LABS INC Approval
06/16/2015 STIOLTO RESPIMAT
NDA #206756		 SUPPL-1 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
06/17/2015 CALCIUM DISODIUM VERSENATE
NDA #008922		 SUPPL-19 EDETATE CALCIUM DISODIUM BAUSCH Manufacturing (CMC) Approval
06/17/2015 RESERPINE
NDA #009838		 SUPPL-40 RESERPINE SANDOZ Manufacturing (CMC) Approval
06/17/2015 IOSAT
NDA #018664		 SUPPL-16 POTASSIUM IODIDE ANBEX Manufacturing (CMC) Approval
06/17/2015 NITROGLYCERIN IN DEXTROSE 5%
NDA #019970		 SUPPL-16 NITROGLYCERIN BAXTER HLTHCARE Manufacturing (CMC) Approval
06/17/2015 LESCOL
NDA #020261		 SUPPL-49 FLUVASTATIN SODIUM NOVARTIS Manufacturing (CMC) Approval
06/17/2015 AVITA
NDA #020400		 SUPPL-6 TRETINOIN MYLAN Manufacturing (CMC) Approval
06/17/2015 GEODON
NDA #020825		 SUPPL-50 ZIPRASIDONE HYDROCHLORIDE VIATRIS Manufacturing (CMC) Approval
06/17/2015 NASCOBAL
NDA #021642		 SUPPL-23 CYANOCOBALAMIN ENDO PHARMS INC Manufacturing (CMC) Approval
06/17/2015 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-13 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
06/17/2015 SAVELLA
NDA #022256		 SUPPL-20 MILNACIPRAN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
06/17/2015 MIRTAZAPINE
ANDA #076541		 SUPPL-18 MIRTAZAPINE SUN PHARM INDS INC Manufacturing (CMC) Approval
06/17/2015 GLIPIZIDE
ANDA #077820		 SUPPL-11 GLIPIZIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
06/17/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200493		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Approval
06/17/2015 GYNAZOLE-1
ANDA #200923		 SUPPL-4 BUTOCONAZOLE NITRATE PADAGIS ISRAEL Labeling Approval
06/18/2015 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-40 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Labeling Approval
06/18/2015 CYMBALTA
NDA #021427		 SUPPL-46 DULOXETINE HYDROCHLORIDE LILLY Labeling Approval
06/18/2015 NITROFURANTOIN
ANDA #091095		 ORIG-1 NITROFURANTOIN, MACROCRYSTALLINE ACTAVIS LABS FL INC Approval
06/18/2015 JEVTANA KIT
NDA #201023		 SUPPL-15 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
06/18/2015 LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473		 ORIG-1 LINEZOLID HOSPIRA Type 5 - New Formulation or New Manufacturer Approval
06/19/2015 HEMABATE
NDA #017989		 SUPPL-23 CARBOPROST TROMETHAMINE PFIZER Manufacturing (CMC) Approval
06/19/2015 CAPOTEN
NDA #018343		 SUPPL-86 CAPTOPRIL STRIDES PHARMA Labeling Approval
06/19/2015 MAGNESIUM SULFATE
NDA #019316		 SUPPL-22 MAGNESIUM SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
06/19/2015 FOSAMAX
NDA #020560		 SUPPL-67 ALENDRONATE SODIUM ORGANON Manufacturing (CMC) Approval
06/19/2015 ZONEGRAN
NDA #020789		 SUPPL-21 ZONISAMIDE CONCORDIA Labeling Approval
06/19/2015 FUZEON
NDA #021481		 SUPPL-29 ENFUVIRTIDE ROCHE Manufacturing (CMC) Approval
06/19/2015 AMPHADASE
BLA #021665		 SUPPL-6 HYALURONIDASE AMPHASTAR PHARM Approval
06/19/2015 VIMOVO
NDA #022511		 SUPPL-16 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON Labeling Approval
06/19/2015 CENTANY
NDA #050788		 SUPPL-5 MUPIROCIN PADAGIS US Labeling Approval
06/19/2015 LOSARTAN POTASSIUM
ANDA #077424		 SUPPL-8 LOSARTAN POTASSIUM CHARTWELL RX Labeling Approval
06/19/2015 SUMATRIPTAN SUCCINATE
ANDA #077744		 SUPPL-4 SUMATRIPTAN SUCCINATE MYLAN Labeling Approval
06/19/2015 SUMATRIPTAN SUCCINATE
ANDA #077744		 SUPPL-5 SUMATRIPTAN SUCCINATE MYLAN Labeling Approval
06/19/2015 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #078218		 SUPPL-3 CYCLOBENZAPRINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/19/2015 KEYTRUDA
BLA #125514		 SUPPL-3 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/19/2015 LAMOTRIGINE
ANDA #201791		 SUPPL-3 LAMOTRIGINE PAR PHARM Labeling Approval
06/19/2015 LAMOTRIGINE
ANDA #201791		 SUPPL-4 LAMOTRIGINE PAR PHARM Labeling Approval
06/19/2015 LAMOTRIGINE
ANDA #201791		 SUPPL-5 LAMOTRIGINE PAR PHARM Labeling Approval
06/19/2015 ENSKYCE
ANDA #201887		 SUPPL-3 DESOGESTREL; ETHINYL ESTRADIOL LUPIN LTD Manufacturing (CMC) Approval
06/19/2015 FYCOMPA
NDA #202834		 SUPPL-5 PERAMPANEL CATALYST PHARMS Efficacy Approval
06/19/2015 XELJANZ
NDA #203214		 SUPPL-10 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
06/19/2015 AZITHROMYCIN
ANDA #203294		 ORIG-1 AZITHROMYCIN EUGIA PHARMA Approval
06/19/2015 ENTACAPONE
ANDA #203437		 ORIG-1 ENTACAPONE AUROBINDO PHARMA LTD Approval
06/19/2015 LEVOFLOXACIN
ANDA #203613		 ORIG-1 LEVOFLOXACIN JUBILANT GENERICS Approval
06/19/2015 OLYSIO
NDA #205123		 SUPPL-7 SIMEPREVIR SODIUM JANSSEN PRODS Manufacturing (CMC) Approval
06/19/2015 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #205128		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ACTAVIS LABS UT INC Approval
06/19/2015 OBREDON
NDA #205474		 SUPPL-1 GUAIFENESIN; HYDROCODONE BITARTRATE SOVEREIGN PHARMS Manufacturing (CMC) Approval
06/19/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-1 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Manufacturing (CMC) Approval
06/22/2015 GENOTROPIN
BLA #020280		 SUPPL-78 SOMATROPIN PHARMACIA Approval
06/22/2015 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-78 SOMATROPIN PHARMACIA Approval
06/22/2015 PRILOSEC OTC
NDA #021229		 SUPPL-26 OMEPRAZOLE MAGNESIUM ASTRAZENECA Labeling Approval
06/22/2015 METOPROLOL TARTRATE
ANDA #073654		 SUPPL-33 METOPROLOL TARTRATE SUN PHARM INDUSTRIES Labeling Approval
06/22/2015 METOPROLOL TARTRATE
ANDA #073654		 SUPPL-34 METOPROLOL TARTRATE SUN PHARM INDUSTRIES Labeling Approval
06/22/2015 DILT-CD
ANDA #076151		 SUPPL-10 DILTIAZEM HYDROCHLORIDE APOTEX Labeling Approval
06/22/2015 TRANDOLAPRIL
ANDA #077805		 SUPPL-6 TRANDOLAPRIL WATSON LABS Labeling Approval
06/22/2015 TRANDOLAPRIL
ANDA #077805		 SUPPL-9 TRANDOLAPRIL WATSON LABS Labeling Approval
06/22/2015 LABETALOL HYDROCHLORIDE
ANDA #079134		 SUPPL-8 LABETALOL HYDROCHLORIDE STERISCIENCE Labeling Approval
06/22/2015 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-6 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
06/22/2015 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-8 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
06/22/2015 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-6 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
06/22/2015 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-8 MONTELUKAST SODIUM STRIDES PHARMA Labeling Approval
06/22/2015 KENGREAL
NDA #204958		 ORIG-1 CANGRELOR CHIESI Type 1 - New Molecular Entity Approval
06/22/2015 PYRIDOSTIGMINE BROMIDE
ANDA #205650		 ORIG-1 PYRIDOSTIGMINE BROMIDE ZYDUS PHARMS Approval
06/22/2015 TUXARIN ER
NDA #206323		 ORIG-1 CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE MAINPOINTE Type 4 - New Combination Approval
06/23/2015 NUTROPIN AQ
BLA #020522		 SUPPL-55 SOMATROPIN GENENTECH Approval
06/23/2015 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-55 SOMATROPIN GENENTECH Approval
06/23/2015 NUTROPIN AQ PEN
BLA #020522		 SUPPL-55 SOMATROPIN GENENTECH Approval
06/23/2015 DICLEGIS
NDA #021876		 SUPPL-7 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
06/23/2015 CLEVIPREX
NDA #022156		 SUPPL-5 CLEVIDIPINE CHIESI Manufacturing (CMC) Approval
06/23/2015 TYVASO
NDA #022387		 SUPPL-12 TREPROSTINIL UNITED THERAP Manufacturing (CMC) Approval
06/23/2015 SUBOXONE
NDA #022410		 SUPPL-21 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
06/23/2015 VASCEPA
NDA #202057		 SUPPL-12 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
06/23/2015 FLUDEOXYGLUCOSE F18
ANDA #203920		 ORIG-1 FLUDEOXYGLUCOSE F-18 JUBILANT DRAXIMAGE Approval
06/23/2015 FLUDEOXYGLUCOSE F18
ANDA #204498		 ORIG-1 FLUDEOXYGLUCOSE F-18 UNIV UTAH CYCLOTRON Approval
06/23/2015 AMMONIA N 13
ANDA #204539		 ORIG-1 AMMONIA N-13 CENTRAL RADIOPHARM Approval
06/23/2015 NEXIUM 24HR
NDA #204655		 SUPPL-3 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Manufacturing (CMC) Approval
06/24/2015 ZORTRESS
NDA #021560		 SUPPL-14 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
06/24/2015 M.V.I. ADULT
NDA #021625		 SUPPL-20 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
06/24/2015 EXELON
NDA #022083		 SUPPL-21 RIVASTIGMINE SANDOZ Manufacturing (CMC) Approval
06/24/2015 BRILINTA
NDA #022433		 SUPPL-14 TICAGRELOR ASTRAZENECA Manufacturing (CMC) Approval
06/24/2015 AFREZZA
BLA #022472		 SUPPL-6 INSULIN RECOMBINANT HUMAN MANNKIND Approval
06/24/2015 AFREZZA
BLA #022472		 SUPPL-8 INSULIN RECOMBINANT HUMAN MANNKIND Approval
06/24/2015 ORACEA
NDA #050805		 SUPPL-9 DOXYCYCLINE GALDERMA LABS LP Manufacturing (CMC) Approval
06/24/2015 STAVUDINE
ANDA #078957		 SUPPL-5 STAVUDINE HETERO LABS LTD III Manufacturing (CMC) Approval
06/24/2015 OXYCODONE AND ACETAMINOPHEN
ANDA #090177		 SUPPL-5 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
06/24/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #090750		 SUPPL-3 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
06/24/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #090750		 SUPPL-3 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
06/24/2015 NEBIVOLOL HYDROCHLORIDE
ANDA #203741		 ORIG-1 NEBIVOLOL HYDROCHLORIDE ALKEM LABS LTD Approval
06/24/2015 ZYKADIA
NDA #205755		 SUPPL-2 CERITINIB NOVARTIS Manufacturing (CMC) Approval
06/25/2015 BANZEL
NDA #021911		 SUPPL-13 RUFINAMIDE EISAI INC Labeling Approval
06/25/2015 ZUPLENZ
NDA #022524		 SUPPL-4 ONDANSETRON AQUESTIVE Manufacturing (CMC) Approval
06/25/2015 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #040498		 SUPPL-11 DIPHENHYDRAMINE HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
06/25/2015 ROCEPHIN
ANDA #063239		 SUPPL-13 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
06/25/2015 NADOLOL
ANDA #074172		 SUPPL-14 NADOLOL RISING Labeling Approval
06/25/2015 NADOLOL
ANDA #074172		 SUPPL-15 NADOLOL RISING Labeling Approval
06/25/2015 ESCITALOPRAM OXALATE
ANDA #078169		 SUPPL-5 ESCITALOPRAM OXALATE CHARTWELL RX Labeling Approval
06/25/2015 FLUOCINOLONE ACETONIDE
ANDA #091514		 ORIG-1 FLUOCINOLONE ACETONIDE SAPTALIS PHARMS Approval
06/25/2015 BANZEL
NDA #201367		 SUPPL-5 RUFINAMIDE EISAI INC Labeling Approval
06/25/2015 AMYVID
NDA #202008		 SUPPL-23 FLORBETAPIR F-18 AVID RADIOPHARMS INC Manufacturing (CMC) Approval
06/25/2015 MONTELUKAST SODIUM
ANDA #202859		 SUPPL-2 MONTELUKAST SODIUM UNIMARK REMEDIES LTD Manufacturing (CMC) Approval
06/26/2015 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-37 METHADONE HYDROCHLORIDE HIKMA REMS Approval
06/26/2015 TIS-U-SOL
NDA #018508		 SUPPL-22 MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE Manufacturing (CMC) Approval
06/26/2015 BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #018802		 SUPPL-26 STERILE WATER FOR INJECTION HOSPIRA Manufacturing (CMC) Approval
06/26/2015 MS CONTIN
NDA #019516		 SUPPL-46 MORPHINE SULFATE PURDUE PHARMA LP REMS Approval
06/26/2015 DURAGESIC-100
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 DURAGESIC-12
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 DURAGESIC-25
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 DURAGESIC-37
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 DURAGESIC-50
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 DURAGESIC-75
NDA #019813		 SUPPL-66 FENTANYL JANSSEN PHARMS REMS Approval
06/26/2015 KADIAN
NDA #020616		 SUPPL-54 MORPHINE SULFATE ALLERGAN REMS Approval
06/26/2015 EXALGO
NDA #021217		 SUPPL-15 HYDROMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
06/26/2015 KALETRA
NDA #021226		 SUPPL-40 LOPINAVIR; RITONAVIR ABBVIE Efficacy Approval
06/26/2015 KALETRA
NDA #021251		 SUPPL-49 LOPINAVIR; RITONAVIR ABBVIE Efficacy Approval
06/26/2015 AVINZA
NDA #021260		 SUPPL-24 MORPHINE SULFATE KING PHARMS LLC Supplement Approval
06/26/2015 BUTRANS
NDA #021306		 SUPPL-22 BUPRENORPHINE PURDUE PHARMA LP REMS Approval
06/26/2015 OPANA ER
NDA #021610		 SUPPL-20 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS REMS Approval
06/26/2015 KALETRA
NDA #021906		 SUPPL-42 LOPINAVIR; RITONAVIR ABBVIE Efficacy Approval
06/26/2015 OXYCONTIN
NDA #022272		 SUPPL-28 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
06/26/2015 EMBEDA
NDA #022321		 SUPPL-19 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS REMS Approval
06/26/2015 METHADOSE
ANDA #040050		 SUPPL-19 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-12 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #040517		 SUPPL-15 METHADONE HYDROCHLORIDE SPECGX LLC REMS Approval
06/26/2015 CEFTIN
NDA #050605		 SUPPL-47 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
06/26/2015 CEFTIN
NDA #050672		 SUPPL-33 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
06/26/2015 MORPHINE SULFATE
ANDA #074769		 SUPPL-22 MORPHINE SULFATE RHODES PHARMS REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #074862		 SUPPL-22 MORPHINE SULFATE RHODES PHARMS REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #075295		 SUPPL-41 MORPHINE SULFATE STRIDES PHARMA REMS Approval
06/26/2015 FENTANYL-100
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-12
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-25
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-37
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-50
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-62
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-75
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 FENTANYL-87
ANDA #076258		 SUPPL-31 FENTANYL MYLAN TECHNOLOGIES REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #076412		 SUPPL-20 MORPHINE SULFATE SPECGX LLC REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #076438		 SUPPL-17 MORPHINE SULFATE SPECGX LLC REMS Approval
06/26/2015 FENTANYL-100
ANDA #076709		 SUPPL-25 FENTANYL ACTAVIS LABS UT INC REMS Approval
06/26/2015 FENTANYL-25
ANDA #076709		 SUPPL-25 FENTANYL ACTAVIS LABS UT INC REMS Approval
06/26/2015 FENTANYL-50
ANDA #076709		 SUPPL-25 FENTANYL ACTAVIS LABS UT INC REMS Approval
06/26/2015 FENTANYL-75
ANDA #076709		 SUPPL-25 FENTANYL ACTAVIS LABS UT INC REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #076720		 SUPPL-17 MORPHINE SULFATE NESHER PHARMS REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #076733		 SUPPL-16 MORPHINE SULFATE NESHER PHARMS REMS Approval
06/26/2015 FENTANYL-100
ANDA #077062		 SUPPL-27 FENTANYL MAYNE PHARMA REMS Approval
06/26/2015 FENTANYL-25
ANDA #077062		 SUPPL-27 FENTANYL MAYNE PHARMA REMS Approval
06/26/2015 FENTANYL-50
ANDA #077062		 SUPPL-27 FENTANYL MAYNE PHARMA REMS Approval
06/26/2015 FENTANYL-75
ANDA #077062		 SUPPL-27 FENTANYL MAYNE PHARMA REMS Approval
06/26/2015 FENTANYL-100
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-12
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-25
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-37
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-50
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-62
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 FENTANYL-75
ANDA #077154		 SUPPL-11 FENTANYL SPECGX LLC REMS Approval
06/26/2015 ZIDOVUDINE
ANDA #077267		 SUPPL-15 ZIDOVUDINE AUROBINDO Labeling Approval
06/26/2015 FENTANYL-100
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-12
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-25
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-37
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-50
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-62
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-75
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-87
ANDA #077449		 SUPPL-15 FENTANYL AVEVA REMS Approval
06/26/2015 FENTANYL-100
ANDA #077775		 SUPPL-19 FENTANYL NOVEN REMS Approval
06/26/2015 FENTANYL-25
ANDA #077775		 SUPPL-19 FENTANYL NOVEN REMS Approval
06/26/2015 FENTANYL-50
ANDA #077775		 SUPPL-19 FENTANYL NOVEN REMS Approval
06/26/2015 FENTANYL-75
ANDA #077775		 SUPPL-19 FENTANYL NOVEN REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #077855		 SUPPL-13 MORPHINE SULFATE NESHER PHARMS REMS Approval
06/26/2015 ZIDOVUDINE
ANDA #078128		 SUPPL-11 ZIDOVUDINE AUROBINDO PHARMA LTD Labeling Approval
06/26/2015 EZETIMIBE
ANDA #078560		 ORIG-1 EZETIMIBE GLENMARK PHARMS LTD Approval
06/26/2015 MORPHINE SULFATE
ANDA #078761		 SUPPL-7 MORPHINE SULFATE SUN PHARM INDS LTD REMS Approval
06/26/2015 ZIDOVUDINE
ANDA #078922		 SUPPL-9 ZIDOVUDINE MYLAN PHARMS INC Labeling Approval
06/26/2015 ZIDOVUDINE
ANDA #078922		 SUPPL-10 ZIDOVUDINE MYLAN PHARMS INC Labeling Approval
06/26/2015 MORPHINE SULFATE
ANDA #079040		 SUPPL-10 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #079046		 SUPPL-21 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #079087		 SUPPL-18 OXYMORPHONE HYDROCHLORIDE IMPAX LABS REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-36 METHADONE HYDROCHLORIDE HIKMA REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-27 METHADONE HYDROCHLORIDE HIKMA REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-32 METHADONE HYDROCHLORIDE HIKMA REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #090635		 SUPPL-10 METHADONE HYDROCHLORIDE THEPHARMANETWORK LLC REMS Approval
06/26/2015 METHADONE HYDROCHLORIDE
ANDA #090707		 SUPPL-6 METHADONE HYDROCHLORIDE VISTAPHARM LLC REMS Approval
06/26/2015 NUCYNTA ER
NDA #200533		 SUPPL-12 TAPENTADOL HYDROCHLORIDE COLLEGIUM PHARM INC REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #200792		 SUPPL-1 OXYMORPHONE HYDROCHLORIDE PAR PHARM REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #200812		 SUPPL-6 MORPHINE SULFATE STRIDES PHARMA REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #200822		 SUPPL-4 OXYMORPHONE HYDROCHLORIDE HIKMA REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #200824		 SUPPL-12 MORPHINE SULFATE RISING REMS Approval
06/26/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #201653		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE SUN PHARM INDS LTD Approval
06/26/2015 OPANA ER
NDA #201655		 SUPPL-17 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #202104		 SUPPL-5 MORPHINE SULFATE UPSHER SMITH LABS REMS Approval
06/26/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #202144		 SUPPL-7 HYDROMORPHONE HYDROCHLORIDE ACTAVIS LABS FL INC REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #202718		 SUPPL-2 MORPHINE SULFATE TEVA PHARMS USA REMS Approval
06/26/2015 ZOHYDRO ER
NDA #202880		 SUPPL-6 HYDROCODONE BITARTRATE RECRO GAINESVILLE REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #202946		 SUPPL-2 OXYMORPHONE HYDROCHLORIDE SPECGX LLC REMS Approval
06/26/2015 OXYMORPHONE HYDROCHLORIDE
ANDA #203506		 SUPPL-1 OXYMORPHONE HYDROCHLORIDE SUN PHARM INDS LTD REMS Approval
06/26/2015 MORPHINE SULFATE
ANDA #203849		 SUPPL-1 MORPHINE SULFATE ACTAVIS ELIZABETH REMS Approval
06/26/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 SUPPL-1 HYDROMORPHONE HYDROCHLORIDE PADAGIS US REMS Approval
06/26/2015 KERYDIN
NDA #204427		 SUPPL-4 TAVABOROLE ANACOR PHARMS INC Manufacturing (CMC) Approval
06/26/2015 JARDIANCE
NDA #204629		 SUPPL-1 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Efficacy Approval
06/26/2015 JARDIANCE
NDA #204629		 SUPPL-2 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Efficacy Approval
06/26/2015 JARDIANCE
NDA #204629		 SUPPL-3 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Efficacy Approval
06/26/2015 PYRIDOSTIGMINE BROMIDE
ANDA #204737		 ORIG-1 PYRIDOSTIGMINE BROMIDE ALVOGEN Approval
06/26/2015 TARGINIQ
NDA #205777		 SUPPL-2 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP REMS Approval
06/26/2015 HYSINGLA ER
NDA #206627		 SUPPL-1 HYDROCODONE BITARTRATE PURDUE PHARMA LP REMS Approval
06/29/2015 KETOROLAC TROMETHAMINE
ANDA #074761		 SUPPL-9 KETOROLAC TROMETHAMINE MYLAN Labeling Approval
06/29/2015 BISOPROLOL FUMARATE
ANDA #075831		 SUPPL-10 BISOPROLOL FUMARATE DASH PHARMS NATCO Labeling Approval
06/29/2015 METOPROLOL SUCCINATE
ANDA #076862		 SUPPL-6 METOPROLOL SUCCINATE ACTAVIS LABS FL INC Labeling Approval
06/29/2015 METOPROLOL SUCCINATE
ANDA #076862		 SUPPL-17 METOPROLOL SUCCINATE ACTAVIS LABS FL INC Labeling Approval
06/29/2015 METOPROLOL SUCCINATE
ANDA #077298		 SUPPL-16 METOPROLOL SUCCINATE ACTAVIS LABS FL INC Labeling Approval
06/29/2015 CLOBETASOL PROPIONATE
ANDA #078223		 SUPPL-9 CLOBETASOL PROPIONATE ACTAVIS MID ATLANTIC Labeling Approval
06/29/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090229		 SUPPL-7 LEVOCETIRIZINE DIHYDROCHLORIDE SYNTHON PHARMS Labeling Approval
06/29/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090229		 SUPPL-8 LEVOCETIRIZINE DIHYDROCHLORIDE SYNTHON PHARMS Labeling Approval
06/29/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090229		 SUPPL-13 LEVOCETIRIZINE DIHYDROCHLORIDE SYNTHON PHARMS Manufacturing (CMC) Approval
06/29/2015 TRI-LO-ESTARYLLA
ANDA #091232		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE XIROMED Approval
06/29/2015 NAPROXEN
ANDA #091416		 SUPPL-1 NAPROXEN MARKSANS PHARMA Labeling Approval
06/29/2015 CALCIUM ACETATE
ANDA #202315		 ORIG-1 CALCIUM ACETATE HERITAGE PHARMS INC Approval
06/29/2015 HYDRALAZINE HYDROCHLORIDE
ANDA #203110		 ORIG-1 HYDRALAZINE HYDROCHLORIDE ADRASTEA PHARMA Approval
06/29/2015 DESVENLAFAXINE SUCCINATE
ANDA #204003		 ORIG-1 DESVENLAFAXINE SUCCINATE ALEMBIC Approval
06/29/2015 DESVENLAFAXINE SUCCINATE
ANDA #204028		 ORIG-1 DESVENLAFAXINE SUCCINATE RUBICON Approval
06/29/2015 DESVENLAFAXINE SUCCINATE
ANDA #204095		 ORIG-1 DESVENLAFAXINE SUCCINATE MYLAN Approval
06/29/2015 DESVENLAFAXINE SUCCINATE
ANDA #204172		 ORIG-1 DESVENLAFAXINE SUCCINATE LUPIN LTD Approval
06/30/2015 PATADAY TWICE DAILY RELIEF
NDA #020688		 SUPPL-28 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Manufacturing (CMC) Approval
06/30/2015 ANGELIQ
NDA #021355		 SUPPL-6 DROSPIRENONE; ESTRADIOL BAYER HLTHCARE Labeling Approval
06/30/2015 ENJUVIA
NDA #021443		 SUPPL-9 ESTROGENS, CONJUGATED SYNTHETIC B ASPEN Labeling Approval
06/30/2015 PREVACID 24 HR
NDA #022327		 SUPPL-22 LANSOPRAZOLE PERRIGO PHARMA INTL Labeling Approval
06/30/2015 JANTOVEN
ANDA #040416		 SUPPL-28 WARFARIN SODIUM UPSHER SMITH LABS Labeling Approval
06/30/2015 ROCEPHIN
NDA #050585		 SUPPL-67 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
06/30/2015 ROCEPHIN KIT
NDA #050585		 SUPPL-67 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Labeling Approval
06/30/2015 DOXYCYCLINE HYCLATE
ANDA #062269		 SUPPL-24 DOXYCYCLINE HYCLATE CARIBE HOLDINGS Labeling Approval
06/30/2015 DOXYCYCLINE HYCLATE
ANDA #062337		 SUPPL-25 DOXYCYCLINE HYCLATE STRIDES PHARMA Labeling Approval
06/30/2015 DOXYCYCLINE HYCLATE
ANDA #062432		 SUPPL-26 DOXYCYCLINE HYCLATE MYLAN Labeling Approval
06/30/2015 GENGRAF
ANDA #065003		 SUPPL-10 CYCLOSPORINE ABBVIE Labeling Approval
06/30/2015 GENGRAF
ANDA #065003		 SUPPL-17 CYCLOSPORINE ABBVIE Labeling Approval
06/30/2015 GENGRAF
ANDA #065003		 SUPPL-18 CYCLOSPORINE ABBVIE Labeling Approval
06/30/2015 CYCLOSPORINE
ANDA #065151		 SUPPL-10 CYCLOSPORINE PADAGIS US Labeling Approval
06/30/2015 CYCLOSPORINE
ANDA #065151		 SUPPL-13 CYCLOSPORINE PADAGIS US Labeling Approval
06/30/2015 ATENOLOL AND CHLORTHALIDONE
ANDA #073582		 SUPPL-36 ATENOLOL; CHLORTHALIDONE SUN PHARM INDUSTRIES Labeling Approval
06/30/2015 ATENOLOL AND CHLORTHALIDONE
ANDA #073582		 SUPPL-37 ATENOLOL; CHLORTHALIDONE SUN PHARM INDUSTRIES Labeling Approval
06/30/2015 PIROXICAM
ANDA #074118		 SUPPL-5 PIROXICAM NOSTRUM LABS INC Labeling Approval
06/30/2015 PIROXICAM
ANDA #074118		 SUPPL-8 PIROXICAM NOSTRUM LABS INC Labeling Approval
06/30/2015 PIROXICAM
ANDA #074118		 SUPPL-9 PIROXICAM NOSTRUM LABS INC Labeling Approval
06/30/2015 KETOROLAC TROMETHAMINE
ANDA #074754		 SUPPL-17 KETOROLAC TROMETHAMINE TEVA Labeling Approval
06/30/2015 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-27 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
06/30/2015 TESTOSTERONE
ANDA #076744		 SUPPL-3 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/30/2015 TESTOSTERONE
ANDA #076744		 SUPPL-4 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/30/2015 TESTOSTERONE
ANDA #076744		 SUPPL-6 TESTOSTERONE STRIDES PHARMA Labeling Approval
06/30/2015 SERTRALINE HYDROCHLORIDE
ANDA #076881		 SUPPL-3 SERTRALINE HYDROCHLORIDE ACI Labeling Approval
06/30/2015 SERTRALINE HYDROCHLORIDE
ANDA #076881		 SUPPL-6 SERTRALINE HYDROCHLORIDE ACI Labeling Approval
06/30/2015 GLIMEPIRIDE
ANDA #077911		 SUPPL-2 GLIMEPIRIDE CARLSBAD Labeling Approval
06/30/2015 ZIDOVUDINE
ANDA #077981		 SUPPL-19 ZIDOVUDINE CIPLA LTD Labeling Approval
06/30/2015 ZIDOVUDINE
ANDA #077981		 SUPPL-20 ZIDOVUDINE CIPLA LTD Labeling Approval
06/30/2015 ZIDOVUDINE
ANDA #077981		 SUPPL-22 ZIDOVUDINE CIPLA LTD Labeling Approval
06/30/2015 FAMCICLOVIR
ANDA #078278		 SUPPL-6 FAMCICLOVIR CIPLA Labeling Approval
06/30/2015 TRANDOLAPRIL
ANDA #078493		 SUPPL-2 TRANDOLAPRIL DR REDDYS LABS LTD Labeling Approval
06/30/2015 TRANDOLAPRIL
ANDA #078493		 SUPPL-3 TRANDOLAPRIL DR REDDYS LABS LTD Labeling Approval
06/30/2015 TRAMADOL HYDROCHLORIDE
ANDA #078935		 SUPPL-5 TRAMADOL HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
06/30/2015 TRAMADOL HYDROCHLORIDE
ANDA #078935		 SUPPL-6 TRAMADOL HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
06/30/2015 TRAMADOL HYDROCHLORIDE
ANDA #078935		 SUPPL-9 TRAMADOL HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
06/30/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992		 SUPPL-2 DEXMETHYLPHENIDATE HYDROCHLORIDE INTELLIPHARMACEUTICS Labeling Approval
06/30/2015 GEMCITABINE HYDROCHLORIDE
ANDA #200145		 SUPPL-1 GEMCITABINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/30/2015 GEMCITABINE HYDROCHLORIDE
ANDA #200145		 SUPPL-3 GEMCITABINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/30/2015 GEMCITABINE HYDROCHLORIDE
ANDA #200145		 SUPPL-4 GEMCITABINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/30/2015 GEMCITABINE HYDROCHLORIDE
ANDA #200145		 SUPPL-6 GEMCITABINE HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
06/30/2015 NAPROXEN
ANDA #200429		 SUPPL-4 NAPROXEN AUROBINDO PHARMA Labeling Approval
06/30/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356		 SUPPL-1 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/30/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356		 SUPPL-2 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/30/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356		 SUPPL-4 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/30/2015 BUSPIRONE HYDROCHLORIDE
ANDA #202330		 SUPPL-2 BUSPIRONE HYDROCHLORIDE STRIDES PHARMA Manufacturing (CMC) Approval
06/30/2015 DESLORATADINE
ANDA #202592		 ORIG-1 DESLORATADINE TARO Approval
06/30/2015 NEVIRAPINE
ANDA #207064		 ORIG-1 NEVIRAPINE CIPLA LIMITED Tentative Approval
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