| 01/02/2019 |
HABITROL
NDA #020076 |
SUPPL-51 |
NICOTINE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 01/02/2019 |
METFORMIN HYDROCHLORIDE
ANDA #079118 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/02/2019 |
METFORMIN HYDROCHLORIDE
ANDA #079118 |
SUPPL-9 |
METFORMIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/02/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #204518 |
ORIG-1 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ALEMBIC |
|
Approval |
| 01/02/2019 |
METFORMIN HYDROCHLORIDE
ANDA #209303 |
SUPPL-1 |
METFORMIN HYDROCHLORIDE |
ALIGNSCIENCE PHARMA |
Labeling |
Approval |
| 01/03/2019 |
ALEVE
NDA #020204 |
SUPPL-62 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
| 01/03/2019 |
XOPENEX
NDA #020837 |
SUPPL-44 |
LEVALBUTEROL HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 01/03/2019 |
MUCINEX DM
NDA #021620 |
SUPPL-39 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
RB HLTH |
Manufacturing (CMC) |
Approval |
| 01/03/2019 |
CHILDREN'S CLARITIN
NDA #021891 |
SUPPL-28 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 01/03/2019 |
CLARITIN
NDA #021891 |
SUPPL-28 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 01/03/2019 |
METHOTREXATE SODIUM
ANDA #081235 |
SUPPL-29 |
METHOTREXATE SODIUM |
MYLAN |
Labeling |
Approval |
| 01/03/2019 |
ONCASPAR
BLA #103411 |
SUPPL-5196 |
PEGASPARGASE |
SIGMA TAU |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208002 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
AMNEAL PHARMS CO |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208028 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
INVAGEN PHARMS |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208031 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
LUPIN LTD |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208049 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208055 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
TORRENT |
|
Approval |
| 01/03/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208055 |
ORIG-2 |
LURASIDONE HYDROCHLORIDE |
TORRENT |
|
Tentative Approval |
| 01/03/2019 |
TERIFLUNOMIDE
ANDA #209710 |
ORIG-1 |
TERIFLUNOMIDE |
SANDOZ |
|
Approval |
| 01/03/2019 |
METHADONE HYDROCHLORIDE
ANDA #211228 |
ORIG-1 |
METHADONE HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
| 01/04/2019 |
TRILEPTAL
NDA #021014 |
SUPPL-43 |
OXCARBAZEPINE |
NOVARTIS |
Labeling |
Approval |
| 01/04/2019 |
TRILEPTAL
NDA #021285 |
SUPPL-36 |
OXCARBAZEPINE |
NOVARTIS |
Labeling |
Approval |
| 01/04/2019 |
PLAN B ONE-STEP
NDA #021998 |
SUPPL-6 |
LEVONORGESTREL |
FDN CONSUMER |
Labeling |
Approval |
| 01/04/2019 |
ESTRADIOL
ANDA #040275 |
SUPPL-10 |
ESTRADIOL |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/04/2019 |
TAPAZOLE
ANDA #040320 |
SUPPL-8 |
METHIMAZOLE |
KING PHARMS LLC |
Labeling |
Approval |
| 01/04/2019 |
ESTRADIOL
ANDA #040326 |
SUPPL-14 |
ESTRADIOL |
MYLAN |
Labeling |
Approval |
| 01/04/2019 |
ZIDOVUDINE
ANDA #078349 |
SUPPL-22 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
| 01/04/2019 |
ZIDOVUDINE
ANDA #078349 |
SUPPL-23 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
| 01/04/2019 |
TYSABRI
BLA #125104 |
SUPPL-965 |
NATALIZUMAB |
BIOGEN IDEC |
|
Approval |
| 01/04/2019 |
NAPROXEN SODIUM
ANDA #202807 |
ORIG-1 |
NAPROXEN SODIUM |
CATALENT |
|
Approval |
| 01/04/2019 |
GLYBURIDE
ANDA #203379 |
ORIG-1 |
GLYBURIDE |
CADILA PHARMS LTD |
|
Approval |
| 01/04/2019 |
ROCURONIUM BROMIDE
ANDA #204679 |
SUPPL-1 |
ROCURONIUM BROMIDE |
WEST WARD PHARM CORP |
Labeling |
Approval |
| 01/04/2019 |
PREGABALIN
ANDA #206942 |
ORIG-1 |
PREGABALIN |
TORRENT PHARMS LTD |
|
Tentative Approval |
| 01/04/2019 |
LURASIDONE HYDROCHLORIDE
ANDA #208066 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
SUN PHARM |
|
Approval |
| 01/04/2019 |
APIXABAN
ANDA #210156 |
ORIG-1 |
APIXABAN |
TORRENT PHARMS LLC |
|
Tentative Approval |
| 01/04/2019 |
PROPAFENONE HYDROCHLORIDE
ANDA #210339 |
ORIG-1 |
PROPAFENONE HYDROCHLORIDE |
SINOTHERAPEUTICS INC |
|
Approval |
| 01/04/2019 |
DAPAGLIFLOZIN
ANDA #211442 |
ORIG-1 |
DAPAGLIFLOZIN |
APOTEX INC |
|
Tentative Approval |
| 01/05/2019 |
PLAQUENIL
NDA #009768 |
SUPPL-51 |
HYDROXYCHLOROQUINE SULFATE |
CONCORDIA |
Manufacturing (CMC) |
Approval |
| 01/05/2019 |
COLY-MYCIN S
NDA #050356 |
SUPPL-59 |
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE |
ENDO PHARMS INC |
Labeling |
Approval |
| 01/07/2019 |
LOTENSIN
NDA #019851 |
SUPPL-54 |
BENAZEPRIL HYDROCHLORIDE |
VALIDUS PHARMS |
Labeling |
Approval |
| 01/07/2019 |
FLONASE
NDA #020121 |
SUPPL-45 |
FLUTICASONE PROPIONATE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/07/2019 |
FLOVENT DISKUS 100
NDA #020833 |
SUPPL-34 |
FLUTICASONE PROPIONATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
FLOVENT DISKUS 250
NDA #020833 |
SUPPL-34 |
FLUTICASONE PROPIONATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
FLOVENT DISKUS 50
NDA #020833 |
SUPPL-34 |
FLUTICASONE PROPIONATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ADVAIR DISKUS 100/50
NDA #021077 |
SUPPL-61 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ADVAIR DISKUS 250/50
NDA #021077 |
SUPPL-61 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ADVAIR DISKUS 500/50
NDA #021077 |
SUPPL-61 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ADVAIR HFA
NDA #021254 |
SUPPL-28 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
FLOVENT HFA
NDA #021433 |
SUPPL-34 |
FLUTICASONE PROPIONATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ARIPIPRAZOLE
ANDA #090472 |
ORIG-1 |
ARIPIPRAZOLE |
ZYDUS PHARMS |
|
Approval |
| 01/07/2019 |
CERINTA
ANDA #202817 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
SUN PHARM |
|
Approval |
| 01/07/2019 |
BREO ELLIPTA
NDA #204275 |
SUPPL-17 |
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE |
GLAXO GRP LTD |
Labeling |
Approval |
| 01/07/2019 |
ARNUITY ELLIPTA
NDA #205625 |
SUPPL-7 |
FLUTICASONE FUROATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 01/07/2019 |
LINEZOLID
ANDA #206097 |
SUPPL-1 |
LINEZOLID |
ZYDUS PHARMS |
Labeling |
Approval |
| 01/07/2019 |
LINEZOLID
ANDA #206097 |
SUPPL-2 |
LINEZOLID |
ZYDUS PHARMS |
Labeling |
Approval |
| 01/07/2019 |
ABIRATERONE ACETATE
ANDA #208327 |
ORIG-1 |
ABIRATERONE ACETATE |
AMNEAL PHARMS |
|
Approval |
| 01/07/2019 |
INGENOL MEBUTATE
ANDA #209018 |
ORIG-1 |
INGENOL MEBUTATE |
PADAGIS ISRAEL |
|
Approval |
| 01/07/2019 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-2 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 01/07/2019 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-3 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 01/07/2019 |
TERIFLUNOMIDE
ANDA #209690 |
ORIG-1 |
TERIFLUNOMIDE |
ACCORD HLTHCARE |
|
Approval |
| 01/08/2019 |
BILTRICIDE
NDA #018714 |
SUPPL-18 |
PRAZIQUANTEL |
BAYER HLTHCARE |
Labeling |
Approval |
| 01/08/2019 |
DOCEFREZ
NDA #022534 |
SUPPL-7 |
DOCETAXEL |
SUN PHARM |
Efficacy |
Approval |
| 01/08/2019 |
DOCETAXEL
NDA #022534 |
SUPPL-7 |
DOCETAXEL |
SUN PHARM |
Efficacy |
Approval |
| 01/08/2019 |
ZIDOVUDINE
ANDA #077981 |
SUPPL-26 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
| 01/08/2019 |
ZIDOVUDINE
ANDA #077981 |
SUPPL-27 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
| 01/08/2019 |
ZIDOVUDINE
ANDA #077981 |
SUPPL-28 |
ZIDOVUDINE |
CIPLA LTD |
Labeling |
Approval |
| 01/08/2019 |
PEGINTRON
BLA #103949 |
SUPPL-5313 |
PEGINTERFERON ALFA-2B |
SCHERING |
|
Approval |
| 01/08/2019 |
SYLATRON
BLA #103949 |
SUPPL-5313 |
PEGINTERFERON ALFA-2B |
SCHERING |
|
Approval |
| 01/08/2019 |
RIVASTIGMINE
ANDA #207308 |
ORIG-1 |
RIVASTIGMINE |
AMNEAL PHARMS |
|
Approval |
| 01/08/2019 |
MYCOPHENOLATE MOFETIL
ANDA #210181 |
ORIG-1 |
MYCOPHENOLATE MOFETIL |
CONCORD BIOTECH LTD |
|
Approval |
| 01/09/2019 |
MANNITOL 10%
NDA #016269 |
SUPPL-55 |
MANNITOL |
HOSPIRA |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 15%
NDA #016269 |
SUPPL-55 |
MANNITOL |
HOSPIRA |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 20%
NDA #016269 |
SUPPL-55 |
MANNITOL |
HOSPIRA |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 25%
NDA #016269 |
SUPPL-55 |
MANNITOL |
HOSPIRA |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 5%
NDA #016269 |
SUPPL-55 |
MANNITOL |
HOSPIRA |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 10% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-38 |
MANNITOL |
ICU MEDICAL INC |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 15% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-38 |
MANNITOL |
ICU MEDICAL INC |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 20% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-38 |
MANNITOL |
ICU MEDICAL INC |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 5% IN PLASTIC CONTAINER
NDA #019603 |
SUPPL-38 |
MANNITOL |
ICU MEDICAL INC |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 10% IN PLASTIC CONTAINER
NDA #020006 |
SUPPL-25 |
MANNITOL |
B BRAUN |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 15% IN PLASTIC CONTAINER
NDA #020006 |
SUPPL-25 |
MANNITOL |
B BRAUN |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 20% IN PLASTIC CONTAINER
NDA #020006 |
SUPPL-25 |
MANNITOL |
B BRAUN |
Labeling |
Approval |
| 01/09/2019 |
MANNITOL 5% IN PLASTIC CONTAINER
NDA #020006 |
SUPPL-25 |
MANNITOL |
B BRAUN |
Labeling |
Approval |
| 01/09/2019 |
NATRECOR
NDA #020920 |
SUPPL-36 |
NESIRITIDE |
SCIOS LLC |
Labeling |
Approval |
| 01/09/2019 |
VIMPAT
NDA #022253 |
SUPPL-41 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 01/09/2019 |
VIMPAT
NDA #022254 |
SUPPL-32 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 01/09/2019 |
VIMPAT
NDA #022255 |
SUPPL-23 |
LACOSAMIDE |
UCB INC |
Efficacy |
Approval |
| 01/09/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199 |
SUPPL-12 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 01/09/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199 |
SUPPL-13 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 01/09/2019 |
PROAIR DIGIHALER
NDA #205636 |
SUPPL-12 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 01/09/2019 |
PROAIR RESPICLICK
NDA #205636 |
SUPPL-12 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 01/09/2019 |
OLOPATADINE HYDROCHLORIDE
ANDA #209015 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
APOTEX INC |
|
Tentative Approval |
| 01/09/2019 |
INGENOL MEBUTATE
ANDA #209019 |
ORIG-1 |
INGENOL MEBUTATE |
PADAGIS ISRAEL |
|
Approval |
| 01/09/2019 |
METHYLPREDNISOLONE
ANDA #210985 |
ORIG-1 |
METHYLPREDNISOLONE |
NOVAST LABS |
|
Approval |
| 01/09/2019 |
CINQAIR
BLA #761033 |
SUPPL-10 |
RESLIZUMAB |
TEVA RESPIRATORY LLC |
|
Approval |
| 01/10/2019 |
RITALIN
NDA #010187 |
SUPPL-71 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
RITALIN
NDA #010187 |
SUPPL-82 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
RITALIN-SR
NDA #018029 |
SUPPL-41 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 01/10/2019 |
RITALIN-SR
NDA #018029 |
SUPPL-51 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 01/10/2019 |
FOCALIN
NDA #021278 |
SUPPL-11 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
FOCALIN
NDA #021278 |
SUPPL-19 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
RITALIN LA
NDA #021284 |
SUPPL-16 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
RITALIN LA
NDA #021284 |
SUPPL-29 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
FOCALIN XR
NDA #021802 |
SUPPL-19 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
FOCALIN XR
NDA #021802 |
SUPPL-29 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/10/2019 |
INGREZZA
NDA #209241 |
SUPPL-6 |
VALBENAZINE TOSYLATE |
NEUROCRINE |
Manufacturing (CMC) |
Approval |
| 01/10/2019 |
OLMESARTAN MEDOXOMIL
ANDA #210552 |
ORIG-1 |
OLMESARTAN MEDOXOMIL |
QILU |
|
Approval |
| 01/10/2019 |
FLUOXETINE HYDROCHLORIDE
ANDA #211282 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 01/11/2019 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
NDA #017648 |
SUPPL-71 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/11/2019 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-71 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/11/2019 |
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-71 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/11/2019 |
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-71 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/11/2019 |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
NDA #017648 |
SUPPL-71 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/11/2019 |
CELEXA
NDA #020822 |
SUPPL-51 |
CITALOPRAM HYDROBROMIDE |
ABBVIE |
Labeling |
Approval |
| 01/11/2019 |
LEXAPRO
NDA #021323 |
SUPPL-51 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
| 01/11/2019 |
LEXAPRO
NDA #021365 |
SUPPL-36 |
ESCITALOPRAM OXALATE |
ABBVIE |
Labeling |
Approval |
| 01/11/2019 |
XYZAL
NDA #022064 |
SUPPL-37 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
| 01/11/2019 |
XYZAL
NDA #022157 |
SUPPL-19 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
| 01/11/2019 |
GILENYA
NDA #022527 |
SUPPL-26 |
FINGOLIMOD HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 01/11/2019 |
LISINOPRIL
ANDA #075994 |
SUPPL-53 |
LISINOPRIL |
CHARTWELL RX |
Labeling |
Approval |
| 01/11/2019 |
LISINOPRIL
ANDA #075994 |
SUPPL-56 |
LISINOPRIL |
CHARTWELL RX |
Labeling |
Approval |
| 01/11/2019 |
HUMIRA
BLA #125057 |
SUPPL-411 |
ADALIMUMAB |
ABBVIE INC |
|
Approval |
| 01/11/2019 |
MYCOPHENOLATE MOFETIL
ANDA #203005 |
SUPPL-4 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/11/2019 |
MYCOPHENOLATE MOFETIL
ANDA #203005 |
SUPPL-6 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/11/2019 |
MYCOPHENOLATE MOFETIL
ANDA #203005 |
SUPPL-7 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/11/2019 |
NALBUPHINE HYDROCHLORIDE
ANDA #207595 |
ORIG-1 |
NALBUPHINE HYDROCHLORIDE |
RISING |
|
Approval |
| 01/11/2019 |
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #207762 |
ORIG-1 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
|
Approval |
| 01/11/2019 |
BETAMETHASONE DIPROPIONATE
ANDA #208885 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
ZYDUS PHARMS |
|
Approval |
| 01/11/2019 |
ACYCLOVIR
ANDA #209971 |
ORIG-1 |
ACYCLOVIR |
TORRENT |
|
Approval |
| 01/11/2019 |
CLOBETASOL PROPIONATE
ANDA #211401 |
ORIG-1 |
CLOBETASOL PROPIONATE |
RISING |
|
Approval |
| 01/11/2019 |
LETROZOLE
ANDA #211717 |
ORIG-1 |
LETROZOLE |
EUGIA PHARMA |
|
Approval |
| 01/14/2019 |
METFORMIN HYDROCHLORIDE
ANDA #075973 |
SUPPL-19 |
METFORMIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 01/14/2019 |
METFORMIN HYDROCHLORIDE
ANDA #075973 |
SUPPL-20 |
METFORMIN HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 01/14/2019 |
PIOGLITAZONE HYDROCHLORIDE
ANDA #078670 |
SUPPL-4 |
PIOGLITAZONE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/14/2019 |
PIOGLITAZONE HYDROCHLORIDE
ANDA #078670 |
SUPPL-5 |
PIOGLITAZONE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/14/2019 |
NEVIRAPINE
ANDA #090688 |
ORIG-1 |
NEVIRAPINE |
MACLEODS PHARMS LTD |
|
Approval |
| 01/14/2019 |
HYDROCHLOROTHIAZIDE
ANDA #203561 |
ORIG-1 |
HYDROCHLOROTHIAZIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 01/14/2019 |
BUSULFAN
ANDA #207794 |
ORIG-1 |
BUSULFAN |
NEXUS |
|
Approval |
| 01/14/2019 |
CABOMETYX
NDA #208692 |
SUPPL-3 |
CABOZANTINIB S-MALATE |
EXELIXIS INC |
Efficacy |
Approval |
| 01/14/2019 |
ALOSETRON HYDROCHLORIDE
ANDA #209180 |
ORIG-1 |
ALOSETRON HYDROCHLORIDE |
RISING |
|
Approval |
| 01/14/2019 |
METFORMIN HYDROCHLORIDE
ANDA #209313 |
SUPPL-1 |
METFORMIN HYDROCHLORIDE |
GRANULES |
Labeling |
Approval |
| 01/14/2019 |
VIGABATRIN
ANDA #209822 |
ORIG-1 |
VIGABATRIN |
TEVA PHARMS USA |
|
Approval |
| 01/15/2019 |
DEXEDRINE
NDA #017078 |
SUPPL-52 |
DEXTROAMPHETAMINE SULFATE |
IMPAX LABS INC |
Labeling |
Approval |
| 01/15/2019 |
ZEGERID OTC
NDA #022281 |
SUPPL-13 |
OMEPRAZOLE; SODIUM BICARBONATE |
RILEY CONSUMER |
Labeling |
Approval |
| 01/15/2019 |
ZEGERID OTC
NDA #022283 |
SUPPL-3 |
OMEPRAZOLE; SODIUM BICARBONATE |
RILEY CONSUMER |
Labeling |
Approval |
| 01/15/2019 |
XARELTO
NDA #022406 |
SUPPL-30 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/15/2019 |
XARELTO
NDA #022406 |
SUPPL-32 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #071868 |
SUPPL-29 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #071868 |
SUPPL-30 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #071868 |
SUPPL-31 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #072168 |
SUPPL-28 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #072168 |
SUPPL-29 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #072945 |
SUPPL-24 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
SUDAFED 12 HOUR
ANDA #073585 |
SUPPL-20 |
PSEUDOEPHEDRINE HYDROCHLORIDE |
MCNEIL CONS |
Labeling |
Approval |
| 01/15/2019 |
CYTARABINE
ANDA #075383 |
SUPPL-17 |
CYTARABINE |
HOSPIRA |
Labeling |
Approval |
| 01/15/2019 |
ALENDRONATE SODIUM
ANDA #076768 |
SUPPL-7 |
ALENDRONATE SODIUM |
CIPLA |
Labeling |
Approval |
| 01/15/2019 |
POLOCAINE
ANDA #088653 |
SUPPL-12 |
MEPIVACAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
| 01/15/2019 |
POLOCAINE W/ LEVONORDEFRIN
ANDA #089517 |
SUPPL-6 |
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
| 01/15/2019 |
TRULICITY
BLA #125469 |
SUPPL-23 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
| 01/15/2019 |
ELETRIPTAN HYDROBROMIDE
ANDA #210708 |
ORIG-1 |
ELETRIPTAN HYDROBROMIDE |
AUROBINDO PHARMA |
|
Approval |
| 01/15/2019 |
HYDROXYCHLOROQUINE SULFATE
ANDA #210959 |
ORIG-1 |
HYDROXYCHLOROQUINE SULFATE |
LAURUS |
|
Approval |
| 01/16/2019 |
CLOZARIL
NDA #019758 |
SUPPL-90 |
CLOZAPINE |
HERITAGE LIFE |
REMS |
Approval |
| 01/16/2019 |
TYLENOL
NDA #019872 |
SUPPL-48 |
ACETAMINOPHEN |
J AND J CONSUMER INC |
Labeling |
Approval |
| 01/16/2019 |
LIORESAL
NDA #020075 |
SUPPL-37 |
BACLOFEN |
AMNEAL |
Labeling |
Approval |
| 01/16/2019 |
WELCHOL
NDA #021176 |
SUPPL-44 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 01/16/2019 |
PREVANTICS MAXI SWABSTICK
NDA #021524 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
| 01/16/2019 |
PREVANTICS SWAB
NDA #021524 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
| 01/16/2019 |
PREVANTICS SWABSTICK
NDA #021524 |
SUPPL-20 |
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL |
PROF DSPLS |
Labeling |
Approval |
| 01/16/2019 |
FAZACLO ODT
NDA #021590 |
SUPPL-31 |
CLOZAPINE |
JAZZ |
REMS |
Approval |
| 01/16/2019 |
WELCHOL
NDA #022362 |
SUPPL-23 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 01/16/2019 |
CAPASTAT SULFATE
NDA #050095 |
SUPPL-72 |
CAPREOMYCIN SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/16/2019 |
ESTAZOLAM
ANDA #074818 |
SUPPL-26 |
ESTAZOLAM |
WATSON LABS |
Labeling |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #074949 |
SUPPL-75 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #075417 |
SUPPL-41 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #075713 |
SUPPL-45 |
CLOZAPINE |
SUN PHARM INDS INC |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #076809 |
SUPPL-38 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #090308 |
SUPPL-3 |
CLOZAPINE |
BARR LABS INC |
REMS |
Approval |
| 01/16/2019 |
CAMPATH
BLA #103948 |
SUPPL-5163 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/16/2019 |
CAMPATH
BLA #103948 |
SUPPL-5164 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/16/2019 |
LEMTRADA
BLA #103948 |
SUPPL-5163 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/16/2019 |
LEMTRADA
BLA #103948 |
SUPPL-5164 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #201824 |
SUPPL-9 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #202873 |
SUPPL-5 |
CLOZAPINE |
ACCORD HLTHCARE |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #203039 |
SUPPL-5 |
CLOZAPINE |
TEVA PHARMS USA |
REMS |
Approval |
| 01/16/2019 |
VERSACLOZ
NDA #203479 |
SUPPL-11 |
CLOZAPINE |
TASMAN PHARMA |
REMS |
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #203807 |
SUPPL-6 |
CLOZAPINE |
DR REDDYS LABS SA |
REMS |
Approval |
| 01/16/2019 |
ACETAZOLAMIDE
ANDA #205301 |
ORIG-1 |
ACETAZOLAMIDE |
CADILA |
|
Approval |
| 01/16/2019 |
PRASUGREL
ANDA #206021 |
ORIG-1 |
PRASUGREL HYDROCHLORIDE |
HEC PHARM |
|
Approval |
| 01/16/2019 |
CLOZAPINE
ANDA #206433 |
SUPPL-4 |
CLOZAPINE |
AUROBINDO PHARMA |
REMS |
Approval |
| 01/16/2019 |
ISOSULFAN BLUE
ANDA #210714 |
ORIG-1 |
ISOSULFAN BLUE |
BELOTECA |
|
Approval |
| 01/16/2019 |
TRIENTINE HYDROCHLORIDE
ANDA #211251 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
NAVINTA LLC |
|
Approval |
| 01/17/2019 |
ALDACTAZIDE
NDA #012616 |
SUPPL-78 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
PFIZER |
Labeling |
Approval |
| 01/17/2019 |
LEVEMIR
BLA #021536 |
SUPPL-54 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/17/2019 |
LEVEMIR FLEXPEN
BLA #021536 |
SUPPL-54 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/17/2019 |
LEVEMIR FLEXTOUCH
BLA #021536 |
SUPPL-54 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/17/2019 |
LEVEMIR INNOLET
BLA #021536 |
SUPPL-54 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/17/2019 |
LEVEMIR PENFILL
BLA #021536 |
SUPPL-54 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/17/2019 |
REVATIO
NDA #022473 |
SUPPL-12 |
SILDENAFIL CITRATE |
VIATRIS |
Labeling |
Approval |
| 01/17/2019 |
ATORVASTATIN CALCIUM
ANDA #090548 |
SUPPL-19 |
ATORVASTATIN CALCIUM |
APOTEX INC |
Labeling |
Approval |
| 01/17/2019 |
REVATIO
NDA #203109 |
SUPPL-12 |
SILDENAFIL CITRATE |
VIATRIS |
Labeling |
Approval |
| 01/17/2019 |
IMATINIB MESYLATE
ANDA #208302 |
ORIG-1 |
IMATINIB MESYLATE |
SHILPA |
|
Approval |
| 01/17/2019 |
IMATINIB MESYLATE
ANDA #208429 |
ORIG-1 |
IMATINIB MESYLATE |
CHARTWELL RX |
|
Approval |
| 01/18/2019 |
ENTOCORT EC
NDA #021324 |
SUPPL-18 |
BUDESONIDE |
PADAGIS US |
Labeling |
Approval |
| 01/18/2019 |
NEUPRO
NDA #021829 |
SUPPL-16 |
ROTIGOTINE |
UCB INC |
Labeling |
Approval |
| 01/18/2019 |
INCRELEX
BLA #021839 |
SUPPL-21 |
MECASERMIN RECOMBINANT |
IPSEN INC |
|
Approval |
| 01/18/2019 |
EGRIFTA
BLA #022505 |
SUPPL-11 |
TESAMORELIN ACETATE |
THERATECHNOLOGIES |
|
Approval |
| 01/18/2019 |
TAPAZOLE
ANDA #040320 |
SUPPL-12 |
METHIMAZOLE |
KING PHARMS LLC |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040350 |
SUPPL-23 |
METHIMAZOLE |
MYLAN |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040411 |
SUPPL-28 |
METHIMAZOLE |
CHARTWELL RX |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040547 |
SUPPL-11 |
METHIMAZOLE |
QINGDAO BAHEAL PHARM |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040619 |
SUPPL-4 |
METHIMAZOLE |
DISCOVERY THERAP |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040734 |
SUPPL-7 |
METHIMAZOLE |
HERITAGE PHARMA |
Labeling |
Approval |
| 01/18/2019 |
METHIMAZOLE
ANDA #040870 |
SUPPL-8 |
METHIMAZOLE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 01/18/2019 |
RETACRIT
BLA #125545 |
SUPPL-3 |
EPOETIN ALFA-EPBX |
HOSPIRA INC |
|
Approval |
| 01/18/2019 |
ERIVEDGE
NDA #203388 |
SUPPL-12 |
VISMODEGIB |
GENENTECH |
Efficacy |
Approval |
| 01/18/2019 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204843 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MEITHEAL |
|
Approval |
| 01/18/2019 |
LANSOPRAZOLE
ANDA #207394 |
ORIG-1 |
LANSOPRAZOLE |
ALKEM LABS LTD |
|
Approval |
| 01/18/2019 |
CARFILZOMIB
ANDA #209528 |
ORIG-1 |
CARFILZOMIB |
QILU PHARM CO LTD |
|
Tentative Approval |
| 01/18/2019 |
LEVOTHYROXINE SODIUM
ANDA #209713 |
ORIG-1 |
LEVOTHYROXINE SODIUM |
LUPIN |
|
Approval |
| 01/18/2019 |
MOXIDECTIN
NDA #210867 |
SUPPL-1 |
MOXIDECTIN |
MDGH |
Labeling |
Approval |
| 01/18/2019 |
DAPAGLIFLOZIN
ANDA #211439 |
ORIG-1 |
DAPAGLIFLOZIN |
HETERO LABS UNIT III |
|
Tentative Approval |
| 01/18/2019 |
CYCLOPHOSPHAMIDE
ANDA #211608 |
ORIG-1 |
CYCLOPHOSPHAMIDE |
CIPLA |
|
Approval |
| 01/18/2019 |
ACYCLOVIR
ANDA #211794 |
ORIG-1 |
ACYCLOVIR |
CIPLA |
|
Approval |
| 01/18/2019 |
LIBTAYO
BLA #761097 |
SUPPL-2 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
| 01/18/2019 |
ONTRUZANT
BLA #761100 |
ORIG-1 |
TRASTUZUMAB-DTTB |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
| 01/22/2019 |
PRANDIN
NDA #020741 |
SUPPL-44 |
REPAGLINIDE |
GEMINI LABS LLC |
Labeling |
Approval |
| 01/22/2019 |
REVLIMID
NDA #021880 |
SUPPL-56 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 01/22/2019 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #205401 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ANI PHARMS |
|
Approval |
| 01/22/2019 |
POTASSIUM CHLORIDE
ANDA #206881 |
ORIG-1 |
POTASSIUM CHLORIDE |
STRIDES PHARMA |
|
Approval |
| 01/22/2019 |
DOFETILDE
ANDA #210740 |
ORIG-1 |
DOFETILIDE |
AUROBINDO PHARMA LTD |
|
Approval |
| 01/22/2019 |
TRETINOIN
ANDA #211645 |
ORIG-1 |
TRETINOIN |
TARO |
|
Approval |
| 01/23/2019 |
FLOMAX
NDA #020579 |
SUPPL-33 |
TAMSULOSIN HYDROCHLORIDE |
SANOFI |
Labeling |
Approval |
| 01/23/2019 |
RIFADIN
NDA #050420 |
SUPPL-78 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/23/2019 |
RIMACTANE
NDA #050429 |
SUPPL-86 |
RIFAMPIN |
OXFORD PHARMS |
Labeling |
Approval |
| 01/23/2019 |
RIFADIN
NDA #050627 |
SUPPL-21 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/23/2019 |
RIFATER
NDA #050705 |
SUPPL-13 |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 01/23/2019 |
METHIMAZOLE
ANDA #202068 |
SUPPL-4 |
METHIMAZOLE |
RISING |
Labeling |
Approval |
| 01/23/2019 |
SYNRIBO
NDA #203585 |
SUPPL-6 |
OMACETAXINE MEPESUCCINATE |
TEVA PHARMS INTL |
Labeling |
Approval |
| 01/23/2019 |
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #206661 |
ORIG-1 |
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
APOZEAL PHARMS |
|
Approval |
| 01/23/2019 |
TICAGRELOR
ANDA #208531 |
ORIG-1 |
TICAGRELOR |
AMNEAL |
|
Approval |
| 01/23/2019 |
TICAGRELOR
ANDA #208575 |
ORIG-1 |
TICAGRELOR |
HISUN PHARM HANGZHOU |
|
Approval |
| 01/23/2019 |
CLOBETASOL PROPIONATE
ANDA #208589 |
ORIG-1 |
CLOBETASOL PROPIONATE |
PAI HOLDINGS PHARM |
|
Approval |
| 01/23/2019 |
BRAFTOVI
NDA #210496 |
SUPPL-1 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
| 01/23/2019 |
MEKTOVI
NDA #210498 |
SUPPL-1 |
BINIMETINIB |
ARRAY BIOPHARMA INC |
Efficacy |
Approval |
| 01/24/2019 |
SUBLIMAZE PRESERVATIVE FREE
NDA #016619 |
SUPPL-39 |
FENTANYL CITRATE |
RISING |
Labeling |
Approval |
| 01/24/2019 |
FENTANYL CITRATE
NDA #019101 |
SUPPL-47 |
FENTANYL CITRATE |
HIKMA |
Labeling |
Approval |
| 01/24/2019 |
PENICILLIN G PROCAINE
ANDA #060101 |
SUPPL-39 |
PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
| 01/24/2019 |
TOPIRAMATE
ANDA #079153 |
SUPPL-20 |
TOPIRAMATE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/24/2019 |
TOPIRAMATE
ANDA #079153 |
SUPPL-21 |
TOPIRAMATE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/24/2019 |
BUPROPION HYDROCHLORIDE
ANDA #090693 |
SUPPL-6 |
BUPROPION HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 01/24/2019 |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200492 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
MYLAN LABS LTD |
Labeling |
Approval |
| 01/24/2019 |
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200493 |
SUPPL-4 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
MYLAN LABS LTD |
Labeling |
Approval |
| 01/24/2019 |
DORZOLAMIDE HYDROCHLORIDE
ANDA #205294 |
ORIG-1 |
DORZOLAMIDE HYDROCHLORIDE |
FDC LTD |
|
Approval |
| 01/24/2019 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ALVOGEN |
|
Approval |
| 01/24/2019 |
LYMEPAK
NDA #209844 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
CHARTWELL PHARMA |
Labeling |
Approval |
| 01/24/2019 |
OXYCODONE HYDROCHLORIDE
ANDA #210758 |
SUPPL-1 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 01/24/2019 |
OXYCODONE HYDROCHLORIDE
ANDA #210758 |
SUPPL-3 |
OXYCODONE HYDROCHLORIDE |
SPECGX LLC |
REMS |
Approval |
| 01/25/2019 |
ZOVIRAX
NDA #018603 |
SUPPL-30 |
ACYCLOVIR SODIUM |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 01/25/2019 |
EXIDINE
NDA #019422 |
SUPPL-49 |
CHLORHEXIDINE GLUCONATE |
XTTRIUM |
Manufacturing (CMC) |
Approval |
| 01/25/2019 |
RISPERDAL
NDA #020272 |
SUPPL-82 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
RISPERDAL
NDA #020588 |
SUPPL-70 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
RISPERDAL CONSTA
NDA #021346 |
SUPPL-60 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
RISPERDAL
NDA #021444 |
SUPPL-56 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
INVEGA
NDA #021999 |
SUPPL-36 |
PALIPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113 |
SUPPL-5 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/25/2019 |
ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113 |
SUPPL-5 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/25/2019 |
INVEGA SUSTENNA
NDA #022264 |
SUPPL-29 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
CALDOLOR
NDA #022348 |
SUPPL-13 |
IBUPROFEN |
CUMBERLAND PHARMS |
Manufacturing (CMC) |
Approval |
| 01/25/2019 |
RITUXAN
BLA #103705 |
SUPPL-5454 |
RITUXIMAB |
GENENTECH |
|
Approval |
| 01/25/2019 |
PHOTREXA
NDA #203324 |
SUPPL-6 |
RIBOFLAVIN 5'-PHOSPHATE |
GLAUKOS |
Labeling |
Approval |
| 01/25/2019 |
PHOTREXA VISCOUS IN DEXTRAN 20%
NDA #203324 |
SUPPL-6 |
RIBOFLAVIN 5'-PHOSPHATE |
GLAUKOS |
Labeling |
Approval |
| 01/25/2019 |
OSPHENA
NDA #203505 |
SUPPL-15 |
OSPEMIFENE |
DUCHESNAY |
Efficacy |
Approval |
| 01/25/2019 |
IMBRUVICA
NDA #205552 |
SUPPL-26 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 01/25/2019 |
ESOMEPRAZOLE MAGNESIUM
ANDA #207265 |
SUPPL-1 |
ESOMEPRAZOLE MAGNESIUM |
HEC PHARM |
Manufacturing (CMC) |
Approval |
| 01/25/2019 |
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #207597 |
ORIG-1 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
P AND L |
|
Approval |
| 01/25/2019 |
INVEGA HAFYERA
NDA #207946 |
SUPPL-8 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
INVEGA TRINZA
NDA #207946 |
SUPPL-8 |
PALIPERIDONE PALMITATE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/25/2019 |
BENDAMUSTINE HYDROCHLORIDE
ANDA #209814 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
CELERITY PHARMS |
|
Tentative Approval |
| 01/25/2019 |
EPTIFIBATIDE
ANDA #209864 |
ORIG-1 |
EPTIFIBATIDE |
SLATE RUN PHARMA |
|
Approval |
| 01/25/2019 |
DICYCLOMINE HYDROCHLORIDE
ANDA #210257 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 01/25/2019 |
MEDROXYPROGESTERONE ACETATE
ANDA #210335 |
ORIG-1 |
MEDROXYPROGESTERONE ACETATE |
CIPLA |
|
Approval |
| 01/25/2019 |
SYMTUZA
NDA #210455 |
SUPPL-1 |
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
JANSSEN PRODS |
Labeling |
Approval |
| 01/25/2019 |
IMBRUVICA
NDA #210563 |
SUPPL-2 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 01/25/2019 |
TOSYMRA
NDA #210884 |
ORIG-1 |
SUMATRIPTAN |
TONIX MEDS |
Type 3 - New Dosage Form |
Approval |
| 01/25/2019 |
TRETINOIN
ANDA #211644 |
ORIG-1 |
TRETINOIN |
TARO |
|
Approval |
| 01/25/2019 |
FLUOXETINE HYDROCHLORIDE
ANDA #211721 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 01/25/2019 |
TIZANIDINE HYDROCHLORIDE
ANDA #211798 |
ORIG-1 |
TIZANIDINE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
| 01/25/2019 |
MESALAMINE
ANDA #211858 |
ORIG-1 |
MESALAMINE |
SUN PHARM |
|
Approval |
| 01/25/2019 |
LUMOXITI
BLA #761104 |
SUPPL-1 |
MOXETUMOMAB PASUDOTOX-TDFK |
INNATE PHARMA |
|
Approval |
| 01/28/2019 |
ALEVE
NDA #020204 |
SUPPL-61 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
| 01/28/2019 |
DIGOXIN
ANDA #040282 |
SUPPL-21 |
DIGOXIN |
RISING |
Labeling |
Approval |
| 01/28/2019 |
KETOROLAC TROMETHAMINE
ANDA #075772 |
SUPPL-5 |
KETOROLAC TROMETHAMINE |
HIKMA |
Manufacturing (CMC) |
Approval |
| 01/28/2019 |
AZELASTINE HYDROCHLORIDE
ANDA #077954 |
SUPPL-11 |
AZELASTINE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 01/28/2019 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200541 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN PHARMS |
Labeling |
Approval |
| 01/28/2019 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200541 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORGESTIMATE |
LUPIN PHARMS |
Manufacturing (CMC) |
Approval |
| 01/28/2019 |
PREZCOBIX
NDA #205395 |
SUPPL-12 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/28/2019 |
LACTATED RINGER'S IN PLASTIC CONTAINER
ANDA #209338 |
ORIG-1 |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS KABI USA |
|
Approval |
| 01/28/2019 |
OMEPRAZOLE
NDA #209400 |
SUPPL-5 |
OMEPRAZOLE |
DEXCEL |
Labeling |
Approval |
| 01/28/2019 |
CLINDAMYCIN PHOSPHATE
ANDA #209914 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
ENCUBE ETHICALS |
|
Approval |
| 01/28/2019 |
DESMOPRESSIN ACETATE
ANDA #210371 |
ORIG-1 |
DESMOPRESSIN ACETATE |
ABHAI LLC |
|
Approval |
| 01/28/2019 |
BUPROPION HYDROCHLORIDE
ANDA #211020 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
GRAVITI PHARMS |
|
Approval |
| 01/28/2019 |
SIROLIMUS
ANDA #211040 |
ORIG-1 |
SIROLIMUS |
NOVITIUM PHARMA |
|
Approval |
| 01/28/2019 |
TAZAROTENE
ANDA #211175 |
ORIG-1 |
TAZAROTENE |
FOUGERA PHARMS INC |
|
Approval |
| 01/28/2019 |
NYSTATIN
ANDA #211838 |
ORIG-1 |
NYSTATIN |
TORRENT |
|
Approval |
| 01/29/2019 |
VFEND
NDA #021266 |
SUPPL-39 |
VORICONAZOLE |
PF PRISM CV |
Efficacy |
Approval |
| 01/29/2019 |
VFEND
NDA #021267 |
SUPPL-50 |
VORICONAZOLE |
PF PRISM CV |
Efficacy |
Approval |
| 01/29/2019 |
VFEND
NDA #021630 |
SUPPL-29 |
VORICONAZOLE |
PF PRISM CV |
Efficacy |
Approval |
| 01/29/2019 |
SIGNIFOR
NDA #200677 |
SUPPL-4 |
PASIREOTIDE DIASPARTATE |
RECORDATI RARE |
Labeling |
Approval |
| 01/29/2019 |
SIGNIFOR LAR KIT
NDA #203255 |
SUPPL-5 |
PASIREOTIDE PAMOATE |
RECORDATI RARE |
Labeling |
Approval |
| 01/29/2019 |
ADRENALIN
NDA #204200 |
SUPPL-9 |
EPINEPHRINE |
PAR STERILE PRODUCTS |
Efficacy |
Approval |
| 01/29/2019 |
ADRENALIN
NDA #204640 |
SUPPL-9 |
EPINEPHRINE |
PAR STERILE PRODUCTS |
Efficacy |
Approval |
| 01/29/2019 |
KHEDEZLA
NDA #204683 |
SUPPL-6 |
DESVENLAFAXINE |
OSMOTICA PHARM CORP |
Labeling |
Approval |
| 01/29/2019 |
TREZIX
ANDA #204785 |
SUPPL-7 |
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE |
XSPIRE PHARMA |
REMS |
Approval |
| 01/29/2019 |
ALOGLIPTIN
ANDA #210213 |
ORIG-1 |
ALOGLIPTIN BENZOATE |
MSN LABS PVT LTD |
|
Tentative Approval |
| 01/29/2019 |
ARIPIPRAZOLE
ANDA #210479 |
ORIG-1 |
ARIPIPRAZOLE |
AUROBINDO PHARMA LTD |
|
Approval |
| 01/29/2019 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #210665 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 01/29/2019 |
TREMFYA
BLA #761061 |
SUPPL-1 |
GUSELKUMAB |
JANSSEN BIOTECH |
|
Approval |
| 01/30/2019 |
ALIMTA
NDA #021462 |
SUPPL-53 |
PEMETREXED DISODIUM |
LILLY |
Efficacy |
Approval |
| 01/30/2019 |
ARANESP
BLA #103951 |
SUPPL-5378 |
DARBEPOETIN ALFA |
AMGEN |
|
Approval |
| 01/30/2019 |
WIXELA INHUB
ANDA #208891 |
ORIG-1 |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE |
MYLAN |
|
Approval |
| 01/30/2019 |
EVEKEO ODT
NDA #209905 |
ORIG-1 |
AMPHETAMINE SULFATE |
AZURITY |
Type 3 - New Dosage Form |
Approval |
| 01/30/2019 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #210666 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 01/30/2019 |
GLOPERBA
NDA #210942 |
ORIG-1 |
COLCHICINE |
SCILEX PHARMS |
Type 3 - New Dosage Form |
Approval |
| 01/30/2019 |
DESONIDE
ANDA #210998 |
ORIG-1 |
DESONIDE |
ENCUBE ETHICALS |
|
Approval |
| 01/30/2019 |
FLUOXETINE HYDROCHLORIDE
ANDA #211696 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
UPSHER SMITH LABS |
|
Approval |
| 01/30/2019 |
CLOBAZAM
ANDA #211711 |
ORIG-1 |
CLOBAZAM |
MICRO LABS |
|
Approval |
| 01/31/2019 |
LAMPRENE
NDA #019500 |
SUPPL-14 |
CLOFAZIMINE |
NOVARTIS |
Labeling |
Approval |
| 01/31/2019 |
LOPERAMIDE HYDROCHLORIDE
NDA #021855 |
SUPPL-9 |
LOPERAMIDE HYDROCHLORIDE |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
| 01/31/2019 |
NUEDEXTA
NDA #021879 |
SUPPL-12 |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
AVANIR PHARMS |
Labeling |
Approval |
| 01/31/2019 |
PREZISTA
NDA #021976 |
SUPPL-54 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/31/2019 |
SALONPAS
NDA #022029 |
SUPPL-17 |
MENTHOL; METHYL SALICYLATE |
HISAMITSU PHARM CO |
Labeling |
Approval |
| 01/31/2019 |
ESTRADIOL
ANDA #040114 |
SUPPL-25 |
ESTRADIOL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 01/31/2019 |
SERTRALINE HYDROCHLORIDE
ANDA #078861 |
SUPPL-15 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/31/2019 |
SERTRALINE HYDROCHLORIDE
ANDA #078861 |
SUPPL-16 |
SERTRALINE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/31/2019 |
PREZISTA
NDA #202895 |
SUPPL-25 |
DARUNAVIR |
JANSSEN PRODS |
Labeling |
Approval |
| 01/31/2019 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
SANDOZ |
|
Approval |
| 01/31/2019 |
RANITIDINE HYDROCHLORIDE
ANDA #211289 |
ORIG-1 |
RANITIDINE HYDROCHLORIDE |
VKT PHARMA |
|
Approval |
| 01/31/2019 |
TACROLIMUS
ANDA #211688 |
ORIG-1 |
TACROLIMUS |
ACCORD HLTHCARE |
|
Approval |
