| 01/02/2018 |
EXCEDRIN (MIGRAINE RELIEF)
NDA #020802 |
SUPPL-32 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/02/2018 |
DOXYCYCLINE HYCLATE
ANDA #062031 |
SUPPL-79 |
DOXYCYCLINE HYCLATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 01/02/2018 |
DOXYCYCLINE HYCLATE
ANDA #062031 |
SUPPL-80 |
DOXYCYCLINE HYCLATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 01/02/2018 |
DOXYCYCLINE HYCLATE
ANDA #062421 |
SUPPL-62 |
DOXYCYCLINE HYCLATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 01/02/2018 |
DOXYCYCLINE HYCLATE
ANDA #062421 |
SUPPL-67 |
DOXYCYCLINE HYCLATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 01/02/2018 |
DOXYCYCLINE HYCLATE
ANDA #062421 |
SUPPL-68 |
DOXYCYCLINE HYCLATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 01/02/2018 |
INVOKAMET XR
NDA #205879 |
SUPPL-2 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/03/2018 |
TROKENDI XR
NDA #201635 |
SUPPL-18 |
TOPIRAMATE |
SUPERNUS PHARMS |
Labeling |
Approval |
| 01/04/2018 |
PARNATE
NDA #012342 |
SUPPL-64 |
TRANYLCYPROMINE SULFATE |
CONCORDIA |
Labeling |
Approval |
| 01/04/2018 |
NOXAFIL
NDA #022003 |
SUPPL-22 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
| 01/04/2018 |
PROLIA
BLA #125320 |
SUPPL-182 |
DENOSUMAB |
AMGEN |
|
Approval |
| 01/04/2018 |
XGEVA
BLA #125320 |
SUPPL-182 |
DENOSUMAB |
AMGEN |
|
Approval |
| 01/04/2018 |
DOCETAXEL
ANDA #204193 |
SUPPL-4 |
DOCETAXEL |
DR REDDYS |
Labeling |
Approval |
| 01/04/2018 |
NOXAFIL
NDA #205053 |
SUPPL-6 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/04/2018 |
NOXAFIL
NDA #205596 |
SUPPL-5 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/05/2018 |
ERAXIS
NDA #021632 |
SUPPL-26 |
ANIDULAFUNGIN |
VICURON HOLDINGS |
Labeling |
Approval |
| 01/08/2018 |
COARTEM
NDA #022268 |
SUPPL-19 |
ARTEMETHER; LUMEFANTRINE |
NOVARTIS |
Labeling |
Approval |
| 01/08/2018 |
RIFADIN
NDA #050420 |
SUPPL-77 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/08/2018 |
RIFADIN
NDA #050627 |
SUPPL-20 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/08/2018 |
RIFATER
NDA #050705 |
SUPPL-12 |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/08/2018 |
TETRABENAZINE
ANDA #209284 |
ORIG-1 |
TETRABENAZINE |
DR REDDYS |
|
Approval |
| 01/09/2018 |
UVADEX
NDA #020969 |
SUPPL-10 |
METHOXSALEN |
MALLINCKRODT HOSP |
Labeling |
Approval |
| 01/09/2018 |
ACIPHEX
NDA #020973 |
SUPPL-38 |
RABEPRAZOLE SODIUM |
WOODWARD |
Labeling |
Approval |
| 01/09/2018 |
OPDIVO
BLA #125554 |
SUPPL-35 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 01/09/2018 |
OPDIVO
BLA #125554 |
SUPPL-36 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 01/09/2018 |
OPDIVO
BLA #125554 |
SUPPL-37 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 01/09/2018 |
OPDIVO
BLA #125554 |
SUPPL-38 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 01/09/2018 |
OPDIVO
BLA #125554 |
SUPPL-39 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 01/09/2018 |
JEVTANA KIT
NDA #201023 |
SUPPL-21 |
CABAZITAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/09/2018 |
OSELTAMIVIR PHOSPHATE
ANDA #208348 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
|
Approval |
| 01/09/2018 |
BALCOLTRA
NDA #208612 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AVION PHARMS |
Type 3 - New Dosage Form |
Approval |
| 01/10/2018 |
CHG SCRUB
NDA #019258 |
SUPPL-26 |
CHLORHEXIDINE GLUCONATE |
ECOLAB |
Labeling |
Approval |
| 01/10/2018 |
CIDA-STAT
NDA #019258 |
SUPPL-26 |
CHLORHEXIDINE GLUCONATE |
ECOLAB |
Labeling |
Approval |
| 01/10/2018 |
AZACITIDINE
NDA #208216 |
SUPPL-1 |
AZACITIDINE |
ACTAVIS LLC |
Labeling |
Approval |
| 01/10/2018 |
DUPIXENT
BLA #761055 |
SUPPL-5 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 01/11/2018 |
RAXIBACUMAB
BLA #125349 |
SUPPL-22 |
RAXIBACUMAB |
HUMAN GENOME SCIENCES INC. |
|
Approval |
| 01/11/2018 |
ADEMPAS
NDA #204819 |
SUPPL-11 |
RIOCIGUAT |
BAYER HLTHCARE |
Efficacy |
Approval |
| 01/12/2018 |
CLARITIN
NDA #019658 |
SUPPL-50 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
| 01/12/2018 |
CLARITIN HIVES RELIEF
NDA #019658 |
SUPPL-50 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
| 01/12/2018 |
RAPAMUNE
NDA #021083 |
SUPPL-62 |
SIROLIMUS |
PF PRISM CV |
Labeling |
Approval |
| 01/12/2018 |
RAPAMUNE
NDA #021110 |
SUPPL-81 |
SIROLIMUS |
PF PRISM CV |
Labeling |
Approval |
| 01/12/2018 |
TRISENOX
NDA #021248 |
SUPPL-15 |
ARSENIC TRIOXIDE |
CEPHALON |
Efficacy |
Approval |
| 01/12/2018 |
ZORTRESS
NDA #021560 |
SUPPL-20 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 01/12/2018 |
ZORTRESS
NDA #021560 |
SUPPL-21 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 01/12/2018 |
GILOTRIF
NDA #201292 |
SUPPL-14 |
AFATINIB DIMALEATE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 01/12/2018 |
COMETRIQ
NDA #203756 |
SUPPL-5 |
CABOZANTINIB S-MALATE |
EXELIXIS |
Labeling |
Approval |
| 01/12/2018 |
LYNPARZA
NDA #208558 |
SUPPL-1 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 01/12/2018 |
SINUVA
NDA #209310 |
SUPPL-1 |
MOMETASONE FUROATE |
INTERSECT ENT INC |
Labeling |
Approval |
| 01/12/2018 |
POTASSIUM CHLORIDE
ANDA #209688 |
ORIG-1 |
POTASSIUM CHLORIDE |
TWI PHARMS |
|
Approval |
| 01/16/2018 |
ALEVE PM
NDA #205352 |
SUPPL-10 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
BAYER HLTHCARE |
Labeling |
Approval |
| 01/16/2018 |
REMIFENTANIL HYDROCHLORIDE
ANDA #206223 |
ORIG-1 |
REMIFENTANIL HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 01/16/2018 |
LIDOCAINE
ANDA #210256 |
ORIG-1 |
LIDOCAINE |
TEVA PHARMS USA |
|
Approval |
| 01/17/2018 |
KYPROLIS
NDA #202714 |
SUPPL-17 |
CARFILZOMIB |
ONYX PHARMS AMGEN |
Efficacy |
Approval |
| 01/17/2018 |
JULUCA
NDA #210192 |
SUPPL-1 |
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE |
VIIV HLTHCARE |
Labeling |
Approval |
| 01/17/2018 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #210506 |
ORIG-1 |
HYDROMORPHONE HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
| 01/18/2018 |
MERREM
NDA #050706 |
SUPPL-39 |
MEROPENEM |
PFIZER |
Labeling |
Approval |
| 01/18/2018 |
KYBELLA
NDA #206333 |
SUPPL-1 |
DEOXYCHOLIC ACID |
ABBVIE |
Labeling |
Approval |
| 01/18/2018 |
TIGECYCLINE
NDA #208744 |
ORIG-1 |
TIGECYCLINE |
ACCORD HLTHCARE INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/19/2018 |
NASACORT ALLERGY 24 HOUR
NDA #020468 |
SUPPL-44 |
TRIAMCINOLONE ACETONIDE |
CHATTEM SANOFI |
Labeling |
Approval |
| 01/19/2018 |
MULTIHANCE
NDA #021357 |
SUPPL-14 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Efficacy |
Approval |
| 01/19/2018 |
MULTIHANCE MULTIPACK
NDA #021358 |
SUPPL-13 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Efficacy |
Approval |
| 01/19/2018 |
DOXORUBICIN HYDROCHLORIDE
ANDA #062921 |
SUPPL-26 |
DOXORUBICIN HYDROCHLORIDE |
HIKMA |
Manufacturing (CMC) |
Approval |
| 01/19/2018 |
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
NDA #202106 |
SUPPL-3 |
MEROPENEM |
B BRAUN MEDICAL INC |
Labeling |
Approval |
| 01/19/2018 |
TICAGRELOR
ANDA #208505 |
ORIG-1 |
TICAGRELOR |
SANDOZ INC |
|
Tentative Approval |
| 01/19/2018 |
DOCETAXEL
ANDA #209640 |
ORIG-1 |
DOCETAXEL |
AMNEAL |
|
Approval |
| 01/19/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #210375 |
ORIG-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 01/22/2018 |
DIFLUCAN
NDA #019949 |
SUPPL-68 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 01/22/2018 |
DIFLUCAN
NDA #020090 |
SUPPL-49 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 01/22/2018 |
SPRIX
NDA #022382 |
SUPPL-18 |
KETOROLAC TROMETHAMINE |
ZYLA |
Labeling |
Approval |
| 01/22/2018 |
ESTRADIOL
ANDA #210194 |
ORIG-1 |
ESTRADIOL |
PADAGIS ISRAEL |
|
Approval |
| 01/23/2018 |
COPAXONE
NDA #020622 |
SUPPL-102 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 01/23/2018 |
DALIRESP
NDA #022522 |
SUPPL-9 |
ROFLUMILAST |
ASTRAZENECA |
Efficacy |
Approval |
| 01/23/2018 |
COSENTYX
BLA #125504 |
SUPPL-13 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 01/23/2018 |
ADAPALENE AND BENZOYL PEROXIDE
ANDA #205033 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
PADAGIS ISRAEL |
|
Approval |
| 01/23/2018 |
ENTERO VU 24%
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
LIQUID E-Z-PAQUE
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
READI-CAT 2
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
READI-CAT 2 SMOOTHIE
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
TAGITOL V
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
VARIBAR HONEY
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
VARIBAR NECTAR
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
VARIBAR THIN HONEY
NDA #208143 |
SUPPL-6 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 01/23/2018 |
BUMETANIDE
ANDA #209916 |
ORIG-1 |
BUMETANIDE |
UPSHER SMITH LABS |
|
Approval |
| 01/23/2018 |
CELECOXIB
ANDA #210071 |
ORIG-1 |
CELECOXIB |
CSPC OUYI |
|
Approval |
| 01/24/2018 |
DURAGESIC-100
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-100
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
DURAGESIC-12
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-12
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
DURAGESIC-25
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-25
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
DURAGESIC-37
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-37
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
DURAGESIC-50
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-50
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
DURAGESIC-75
NDA #019813 |
SUPPL-72 |
FENTANYL |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/24/2018 |
DURAGESIC-75
NDA #019813 |
SUPPL-73 |
FENTANYL |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
BUSULFEX
NDA #020954 |
SUPPL-17 |
BUSULFAN |
OTSUKA PHARM |
Labeling |
Approval |
| 01/24/2018 |
NITROSTAT
NDA #021134 |
SUPPL-10 |
NITROGLYCERIN |
VIATRIS |
Labeling |
Approval |
| 01/24/2018 |
AVEED
NDA #022219 |
SUPPL-10 |
TESTOSTERONE UNDECANOATE |
ENDO PHARMS INC |
Labeling |
Approval |
| 01/24/2018 |
RANITIDINE HYDROCHLORIDE
ANDA #076195 |
SUPPL-30 |
RANITIDINE HYDROCHLORIDE |
PERRIGO |
Manufacturing (CMC) |
Approval |
| 01/24/2018 |
PROLIA
BLA #125320 |
SUPPL-185 |
DENOSUMAB |
AMGEN |
|
Approval |
| 01/24/2018 |
XGEVA
BLA #125320 |
SUPPL-185 |
DENOSUMAB |
AMGEN |
|
Approval |
| 01/24/2018 |
NEXIUM 24HR
NDA #204655 |
SUPPL-9 |
ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA LP |
Labeling |
Approval |
| 01/24/2018 |
ADAPALENE AND BENZOYL PEROXIDE
ANDA #206959 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
TARO |
|
Approval |
| 01/24/2018 |
ADAPALENE AND BENZOYL PEROXIDE
ANDA #206959 |
ORIG-2 |
ADAPALENE; BENZOYL PEROXIDE |
TARO |
Labeling |
Approval |
| 01/24/2018 |
TRULANCE
NDA #208745 |
SUPPL-1 |
PLECANATIDE |
SALIX |
Efficacy |
Approval |
| 01/24/2018 |
SYMPROIC
NDA #208854 |
SUPPL-2 |
NALDEMEDINE TOSYLATE |
BDSI |
Labeling |
Approval |
| 01/25/2018 |
VIDEX
NDA #020156 |
SUPPL-53 |
DIDANOSINE |
BRISTOL |
Labeling |
Approval |
| 01/25/2018 |
VIDEX EC
NDA #021183 |
SUPPL-28 |
DIDANOSINE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 01/25/2018 |
PREZISTA
NDA #021976 |
SUPPL-47 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/25/2018 |
PYLERA
NDA #050786 |
SUPPL-17 |
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
LABS JUVISE |
Labeling |
Approval |
| 01/25/2018 |
PREZISTA
NDA #202895 |
SUPPL-21 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/25/2018 |
PREZCOBIX
NDA #205395 |
SUPPL-6 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/25/2018 |
PREZCOBIX
NDA #205395 |
SUPPL-7 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/25/2018 |
LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
NDA #205493 |
ORIG-1 |
LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
MICRO LABS LTD |
Type 4 - New Combination |
Tentative Approval |
| 01/25/2018 |
BUNAVAIL
NDA #205637 |
SUPPL-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
BDSI |
Labeling |
Approval |
| 01/25/2018 |
ORKAMBI
NDA #206038 |
SUPPL-7 |
IVACAFTOR; LUMACAFTOR |
VERTEX PHARMS INC |
Efficacy |
Approval |
| 01/25/2018 |
ARISTADA
NDA #207533 |
SUPPL-9 |
ARIPIPRAZOLE LAUROXIL |
ALKERMES INC |
Labeling |
Approval |
| 01/26/2018 |
DILAUDID
NDA #019034 |
SUPPL-30 |
HYDROMORPHONE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 01/26/2018 |
DILAUDID-HP
NDA #019034 |
SUPPL-30 |
HYDROMORPHONE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800 |
ORIG-2 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
|
Approval |
| 01/26/2018 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090636 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
HETERO LABS LTD III |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090636 |
ORIG-2 |
TENOFOVIR DISOPROXIL FUMARATE |
HETERO LABS LTD III |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
ORIG-2 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647 |
ORIG-3 |
TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090742 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
STRIDES PHARMA |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #091612 |
SUPPL-1 |
TENOFOVIR DISOPROXIL FUMARATE |
TEVA PHARMS USA |
|
Tentative Approval |
| 01/26/2018 |
STRENSIQ
BLA #125513 |
SUPPL-3 |
ASFOTASE ALFA |
ALEXION PHARM |
|
Approval |
| 01/26/2018 |
GEMCITABINE HYDROCHLORIDE
NDA #200795 |
SUPPL-8 |
GEMCITABINE HYDROCHLORIDE |
HOSPIRA INC |
Labeling |
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
|
Approval |
| 01/26/2018 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232 |
ORIG-2 |
TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
|
Approval |
| 01/26/2018 |
INJECTAFER
NDA #203565 |
SUPPL-5 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Efficacy |
Approval |
| 01/26/2018 |
ZYDELIG
NDA #205858 |
SUPPL-9 |
IDELALISIB |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 01/26/2018 |
COTELLIC
NDA #206192 |
SUPPL-2 |
COBIMETINIB FUMARATE |
GENENTECH INC |
Efficacy |
Approval |
| 01/26/2018 |
ARGATROBAN
ANDA #206698 |
ORIG-1 |
ARGATROBAN |
AMNEAL PHARMS CO |
|
Approval |
| 01/26/2018 |
JADENU
NDA #206910 |
SUPPL-5 |
DEFERASIROX |
NOVARTIS PHARMS CORP |
Labeling |
Approval |
| 01/26/2018 |
LUTATHERA
NDA #208700 |
ORIG-1 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Type 1 - New Molecular Entity |
Approval |
| 01/26/2018 |
FIRVANQ KIT
NDA #208910 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
AZURITY |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/26/2018 |
ATROPINE SULFATE
NDA #209260 |
ORIG-1 |
ATROPINE SULFATE |
FRESENIUS KABI USA |
|
Approval |
| 01/26/2018 |
PIROXICAM
ANDA #210347 |
ORIG-1 |
PIROXICAM |
STRIDES PHARMA |
|
Approval |
| 01/26/2018 |
KAPSPARGO SPRINKLE
NDA #210428 |
ORIG-1 |
METOPROLOL SUCCINATE |
SPIL |
Type 3 - New Dosage Form |
Approval |
| 01/26/2018 |
SILIQ
BLA #761032 |
SUPPL-4 |
BRODALUMAB |
VALEANT LUXEMBOURG |
|
Approval |
| 01/26/2018 |
ERELZI
BLA #761042 |
SUPPL-1 |
ETANERCEPT-SZZS |
SANDOZ |
|
Approval |
| 01/29/2018 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119 |
SUPPL-12 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
AKORN |
Labeling |
Approval |
| 01/29/2018 |
LAMOTRIGINE
ANDA #078947 |
SUPPL-26 |
LAMOTRIGINE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/29/2018 |
CAPITAL AND CODEINE
ANDA #086024 |
SUPPL-21 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
VALEANT PHARMS LLC |
Labeling |
Approval |
| 01/29/2018 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508 |
SUPPL-41 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
GENUS LIFESCIENCES |
Labeling |
Approval |
| 01/29/2018 |
SODIUM POLYSTYRENE SULFONATE
ANDA #089910 |
SUPPL-9 |
SODIUM POLYSTYRENE SULFONATE |
CMP PHARMA INC |
Labeling |
Approval |
| 01/29/2018 |
OFEV
NDA #205832 |
SUPPL-9 |
NINTEDANIB ESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/29/2018 |
TRIAMCINOLONE ACETONIDE
ANDA #208848 |
SUPPL-1 |
TRIAMCINOLONE ACETONIDE |
ENCUBE |
Manufacturing (CMC) |
Approval |
| 01/29/2018 |
TESTOSTERONE
ANDA #209533 |
ORIG-1 |
TESTOSTERONE |
CIPLA |
|
Approval |
| 01/29/2018 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #210077 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
STRIDES PHARMA |
|
Approval |
| 01/29/2018 |
CLONIDINE HYDROCHLORIDE
ANDA #210338 |
ORIG-1 |
CLONIDINE HYDROCHLORIDE |
JUBILANT GENERICS |
|
Approval |
| 01/30/2018 |
BIO-TROPIN
BLA #019774 |
SUPPL-29 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
BIO-TROPIN
BLA #019774 |
SUPPL-40 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
BIO-TROPIN
BLA #019774 |
SUPPL-45 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
BIO-TROPIN
BLA #019774 |
SUPPL-47 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
ZOMACTON
BLA #019774 |
SUPPL-29 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
ZOMACTON
BLA #019774 |
SUPPL-40 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
ZOMACTON
BLA #019774 |
SUPPL-45 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
ZOMACTON
BLA #019774 |
SUPPL-47 |
SOMATROPIN |
FERRING |
|
Approval |
| 01/30/2018 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861 |
SUPPL-75 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 01/30/2018 |
AMPICILLIN SODIUM
ANDA #090884 |
SUPPL-1 |
AMPICILLIN SODIUM |
ACS DOBFAR SPA |
Labeling |
Approval |
| 01/30/2018 |
AMPICILLIN SODIUM
ANDA #090884 |
SUPPL-2 |
AMPICILLIN SODIUM |
ACS DOBFAR SPA |
Labeling |
Approval |
| 01/30/2018 |
ARGATROBAN
NDA #201811 |
SUPPL-6 |
ARGATROBAN |
FRESENIUS KABI USA |
Labeling |
Approval |
| 01/30/2018 |
CLOBETASOL PROPIONATE
ANDA #210208 |
ORIG-1 |
CLOBETASOL PROPIONATE |
LUPIN LTD |
|
Approval |
| 01/31/2018 |
METHADONE HYDROCHLORIDE
ANDA #087393 |
SUPPL-44 |
METHADONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 01/31/2018 |
METHADONE HYDROCHLORIDE
ANDA #087997 |
SUPPL-36 |
METHADONE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 01/31/2018 |
METHADONE HYDROCHLORIDE
ANDA #090707 |
SUPPL-14 |
METHADONE HYDROCHLORIDE |
VISTAPHARM LLC |
Labeling |
Approval |
| 01/31/2018 |
METHADONE HYDROCHLORIDE
ANDA #090707 |
SUPPL-15 |
METHADONE HYDROCHLORIDE |
VISTAPHARM LLC |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #090819 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149 |
SUPPL-10 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422 |
SUPPL-20 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422 |
SUPPL-23 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201066 |
SUPPL-6 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201066 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633 |
SUPPL-3 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE
ANDA #201760 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136 |
SUPPL-14 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 01/31/2018 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ETHYPHARM USA CORP |
Labeling |
Approval |
