| 02/01/2022 |
MONOKET
NDA #020215 |
SUPPL-27 |
ISOSORBIDE MONONITRATE |
OMNIVIUM PHARMS |
Manufacturing (CMC) |
Approval |
| 02/01/2022 |
AFINITOR
NDA #022334 |
SUPPL-51 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 02/01/2022 |
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
ANDA #060764 |
SUPPL-19 |
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
PADAGIS US |
Labeling |
Approval |
| 02/01/2022 |
JUXTAPID
NDA #203858 |
SUPPL-23 |
LOMITAPIDE MESYLATE |
CHIESI |
REMS |
Approval |
| 02/01/2022 |
AFINITOR DISPERZ
NDA #203985 |
SUPPL-23 |
EVEROLIMUS |
NOVARTIS PHARM |
Labeling |
Approval |
| 02/01/2022 |
RUZURGI
NDA #209321 |
ORIG-1 |
AMIFAMPRIDINE |
JACOBUS PHARM CO INC |
Type 2 - New Active Ingredient |
Tentative Approval |
| 02/01/2022 |
RUZURGI
NDA #209321 |
SUPPL-1 |
AMIFAMPRIDINE |
JACOBUS PHARM CO INC |
Labeling |
Tentative Approval |
| 02/01/2022 |
APIXABAN
ANDA #210053 |
ORIG-1 |
APIXABAN |
SIGMAPHARM LABS LLC |
|
Tentative Approval |
| 02/01/2022 |
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #214407 |
ORIG-1 |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
L PERRIGO CO |
|
Approval |
| 02/02/2022 |
KADCYLA
BLA #125427 |
SUPPL-111 |
ADO-TRASTUZUMAB EMTANSINE |
GENENTECH |
|
Approval |
| 02/02/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200383 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 02/02/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200383 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NAARI PTE LTD |
Labeling |
Approval |
| 02/02/2022 |
CYCLOSPORINE
ANDA #205894 |
ORIG-1 |
CYCLOSPORINE |
MYLAN |
|
Approval |
| 02/02/2022 |
EZETIMIBE AND SIMVASTATIN
ANDA #208699 |
SUPPL-2 |
EZETIMIBE; SIMVASTATIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/02/2022 |
COPIKTRA
NDA #211155 |
SUPPL-6 |
DUVELISIB |
SECURA |
REMS |
Approval |
| 02/02/2022 |
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ANDA #211695 |
ORIG-1 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
AUROBINDO PHARMA LTD |
|
Approval |
| 02/02/2022 |
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #211925 |
ORIG-1 |
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE |
MICRO LABS |
|
Approval |
| 02/02/2022 |
ATAZANAVIR SULFATE
ANDA #212278 |
ORIG-1 |
ATAZANAVIR SULFATE |
HETERO LABS LTD III |
|
Approval |
| 02/02/2022 |
GAVRETO
NDA #213721 |
SUPPL-5 |
PRALSETINIB |
BLUEPRINT MEDICINES |
Labeling |
Approval |
| 02/02/2022 |
BUPROPION HYDROCHLORIDE
ANDA #215568 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
GRANULES |
|
Approval |
| 02/03/2022 |
PREVIFEM
ANDA #076334 |
SUPPL-23 |
ETHINYL ESTRADIOL; NORGESTIMATE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 02/03/2022 |
TRI-PREVIFEM
ANDA #076335 |
SUPPL-20 |
ETHINYL ESTRADIOL; NORGESTIMATE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 02/03/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #090479 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 02/03/2022 |
NORGESTIMATE; ETHINYL ESTRADIOL
ANDA #090479 |
SUPPL-1 |
NORGESTIMATE; ETHINYL ESTRADIOL |
WATSON LABS |
Labeling |
Approval |
| 02/03/2022 |
MONO-LINYAH
ANDA #090523 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/03/2022 |
TRI-LINYAH
ANDA #090524 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/03/2022 |
TRI-ESTARYLLA
ANDA #090793 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 02/03/2022 |
ESTARYLLA
ANDA #090794 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 02/03/2022 |
TROKENDI XR
NDA #201635 |
SUPPL-29 |
TOPIRAMATE |
SUPERNUS PHARMS |
Labeling |
Approval |
| 02/03/2022 |
XIGDUO XR
NDA #205649 |
SUPPL-16 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
ASTRAZENECA AB |
Efficacy |
Approval |
| 02/03/2022 |
MIGLUSTAT
ANDA #209325 |
ORIG-1 |
MIGLUSTAT |
BRECKENRIDGE |
|
Approval |
| 02/03/2022 |
AZACITIDINE
ANDA #211549 |
ORIG-1 |
AZACITIDINE |
AMNEAL |
|
Approval |
| 02/03/2022 |
APREMILAST
ANDA #211859 |
ORIG-1 |
APREMILAST |
ZYDUS PHARMS |
|
Tentative Approval |
| 02/03/2022 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #213444 |
ORIG-1 |
PRAMIPEXOLE DIHYDROCHLORIDE |
NOVAST LABS |
|
Approval |
| 02/03/2022 |
ACETYLCYSTEINE
ANDA #213693 |
ORIG-1 |
ACETYLCYSTEINE |
ASPEN |
|
Approval |
| 02/03/2022 |
ALKINDI SPRINKLE
NDA #213876 |
SUPPL-1 |
HYDROCORTISONE |
ETON |
Labeling |
Approval |
| 02/03/2022 |
LAMOTRIGINE
ANDA #214124 |
ORIG-1 |
LAMOTRIGINE |
AMRING PHARMS |
|
Approval |
| 02/03/2022 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA #214822 |
ORIG-1 |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
| 02/04/2022 |
CELEXA
NDA #020822 |
SUPPL-41 |
CITALOPRAM HYDROBROMIDE |
ABBVIE |
Labeling |
Approval |
| 02/04/2022 |
KEYTRUDA
BLA #125514 |
SUPPL-95 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 02/04/2022 |
KEYTRUDA
BLA #125514 |
SUPPL-125 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 02/04/2022 |
TAFINLAR
NDA #202806 |
SUPPL-21 |
DABRAFENIB MESYLATE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 02/04/2022 |
INJECTAFER
NDA #203565 |
SUPPL-19 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Manufacturing (CMC) |
Approval |
| 02/04/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #204057 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
GLENMARK PHARMS |
Labeling |
Approval |
| 02/04/2022 |
EPINEPHRINE
NDA #205029 |
SUPPL-9 |
EPINEPHRINE |
BPI LABS |
Manufacturing (CMC) |
Approval |
| 02/04/2022 |
QUDEXY XR
NDA #205122 |
SUPPL-12 |
TOPIRAMATE |
UPSHER SMITH LABS |
Labeling |
Approval |
| 02/04/2022 |
PRASUGREL
ANDA #205913 |
SUPPL-8 |
PRASUGREL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/04/2022 |
VALTOCO
NDA #211635 |
SUPPL-7 |
DIAZEPAM |
NEURELIS INC |
Labeling |
Approval |
| 02/04/2022 |
ARTESUNATE
NDA #213036 |
SUPPL-1 |
ARTESUNATE |
AMIVAS |
Labeling |
Approval |
| 02/04/2022 |
DAPSONE
ANDA #213847 |
ORIG-1 |
DAPSONE |
MYLAN |
|
Approval |
| 02/04/2022 |
POSACONAZOLE
ANDA #214476 |
ORIG-1 |
POSACONAZOLE |
BIOCON PHARMA |
|
Approval |
| 02/04/2022 |
FLEQSUVY
NDA #215602 |
ORIG-1 |
BACLOFEN |
AZURITY |
Type 3 - New Dosage Form |
Approval |
| 02/04/2022 |
TRUXIMA
BLA #761088 |
SUPPL-18 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
| 02/04/2022 |
ENJAYMO
BLA #761164 |
ORIG-1 |
SUTIMLIMAB-JOME |
BIOVERATIV THERAPEUTICS INC |
|
Approval |
| 02/07/2022 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #075768 |
SUPPL-20 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
MYLAN |
Labeling |
Approval |
| 02/07/2022 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #075768 |
SUPPL-22 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
MYLAN |
Labeling |
Approval |
| 02/07/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #078267 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/07/2022 |
MARAVIROC
ANDA #203347 |
ORIG-1 |
MARAVIROC |
HETERO LABS LTD III |
|
Approval |
| 02/07/2022 |
HAILEY 24 FE
ANDA #204847 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/07/2022 |
DAPTOMYCIN
NDA #208385 |
SUPPL-7 |
DAPTOMYCIN |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/07/2022 |
DAPTOMYCIN
NDA #208385 |
SUPPL-8 |
DAPTOMYCIN |
SAGENT PHARMS INC |
Labeling |
Approval |
| 02/07/2022 |
VOCABRIA
NDA #212887 |
SUPPL-2 |
CABOTEGRAVIR SODIUM |
VIIV HLTHCARE |
Efficacy |
Approval |
| 02/07/2022 |
CABENUVA KIT
NDA #212888 |
SUPPL-2 |
CABOTEGRAVIR; RILPIVIRINE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 02/07/2022 |
ARFORMOTEROL TARTRATE
ANDA #213068 |
ORIG-1 |
ARFORMOTEROL TARTRATE |
LUPIN |
|
Approval |
| 02/07/2022 |
SEVELAMER CARBONATE
ANDA #215537 |
ORIG-1 |
SEVELAMER CARBONATE |
MICRO LABS |
|
Approval |
| 02/07/2022 |
MORPHINE SULFATE
ANDA #215584 |
ORIG-1 |
MORPHINE SULFATE |
INGENUS PHARMS NJ |
|
Approval |
| 02/07/2022 |
SUCCINYLCHOLINE CHLORIDE
ANDA #216003 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
BE PHARMS |
|
Approval |
| 02/08/2022 |
PIROXICAM
ANDA #074131 |
SUPPL-28 |
PIROXICAM |
TEVA |
Labeling |
Approval |
| 02/08/2022 |
ADVIL
NDA #201803 |
SUPPL-16 |
IBUPROFEN SODIUM |
HALEON US HOLDINGS |
Labeling |
Approval |
| 02/08/2022 |
CYCLAFEM 0.5/35
ANDA #203413 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
VINTAGE PHARMS |
Labeling |
Approval |
| 02/08/2022 |
NITROFURANTOIN
ANDA #205005 |
SUPPL-1 |
NITROFURANTOIN, MACROCRYSTALLINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/08/2022 |
NITROFURANTOIN
ANDA #205005 |
SUPPL-3 |
NITROFURANTOIN, MACROCRYSTALLINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/08/2022 |
ALEVE PM
NDA #205352 |
SUPPL-16 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/08/2022 |
LUBIPROSTONE
ANDA #206994 |
ORIG-1 |
LUBIPROSTONE |
DR REDDYS |
|
Approval |
| 02/08/2022 |
OXALIPLATIN
ANDA #207474 |
SUPPL-2 |
OXALIPLATIN |
ACCORD HLTHCARE |
Labeling |
Approval |
| 02/08/2022 |
ERTAPENEM SODIUM
ANDA #207647 |
SUPPL-10 |
ERTAPENEM SODIUM |
SAVIOR LIFETEC CORP |
Labeling |
Approval |
| 02/08/2022 |
PHEXXI
NDA #208352 |
SUPPL-2 |
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE |
EVOFEM INC |
Labeling |
Approval |
| 02/08/2022 |
ROSUVASTATIN CALCIUM
ANDA #212059 |
SUPPL-1 |
ROSUVASTATIN CALCIUM |
ZHEJIANG YONGTAI |
Labeling |
Approval |
| 02/08/2022 |
NALMEFENE HYDROCHLORIDE
ANDA #212955 |
ORIG-1 |
NALMEFENE HYDROCHLORIDE |
PURDUE PHARMA LP |
|
Approval |
| 02/08/2022 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #214330 |
ORIG-1 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
NOVITIUM PHARMA |
|
Approval |
| 02/08/2022 |
SILDENAFIL CITRATE
ANDA #214641 |
ORIG-1 |
SILDENAFIL CITRATE |
MSN |
|
Approval |
| 02/08/2022 |
DIGOXIN
ANDA #214982 |
ORIG-1 |
DIGOXIN |
AUROBINDO PHARMA LTD |
|
Approval |
| 02/08/2022 |
TAKHZYRO
BLA #761090 |
SUPPL-3 |
LANADELUMAB-FLYO |
DYAX CORP. |
|
Approval |
| 02/09/2022 |
OCTREOSCAN
NDA #020314 |
SUPPL-12 |
INDIUM IN-111 PENTETREOTIDE KIT |
CURIUM |
Labeling |
Approval |
| 02/09/2022 |
XYREM
NDA #021196 |
SUPPL-39 |
SODIUM OXYBATE |
JAZZ PHARMS |
REMS |
Approval |
| 02/09/2022 |
SUCCINYLCHOLINE CHLORIDE
ANDA #209467 |
SUPPL-7 |
SUCCINYLCHOLINE CHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/09/2022 |
CHLORTHALIDONE
ANDA #211320 |
ORIG-1 |
CHLORTHALIDONE |
INVENTIA |
|
Approval |
| 02/09/2022 |
XYWAV
NDA #212690 |
SUPPL-9 |
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE |
JAZZ |
REMS |
Approval |
| 02/09/2022 |
DOXEPIN HYDROCHLORIDE
ANDA #215710 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
| 02/10/2022 |
NORTREL 1/35-21
ANDA #072693 |
SUPPL-26 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 1/35-21
ANDA #072693 |
SUPPL-27 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 1/35-21
ANDA #072693 |
SUPPL-28 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 0.5/35-28
ANDA #072695 |
SUPPL-24 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 0.5/35-28
ANDA #072695 |
SUPPL-25 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 0.5/35-28
ANDA #072695 |
SUPPL-26 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 1/35-28
ANDA #072696 |
SUPPL-25 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 1/35-28
ANDA #072696 |
SUPPL-27 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
NORTREL 1/35-28
ANDA #072696 |
SUPPL-28 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 02/10/2022 |
QUINIDINE SULFATE
ANDA #088072 |
SUPPL-18 |
QUINIDINE SULFATE |
EPIC PHARMA LLC |
Manufacturing (CMC) |
Approval |
| 02/10/2022 |
NPLATE
BLA #125268 |
SUPPL-172 |
ROMIPLOSTIM |
AMGEN |
|
Approval |
| 02/10/2022 |
TECFIDERA
NDA #204063 |
SUPPL-27 |
DIMETHYL FUMARATE |
BIOGEN INC |
Labeling |
Approval |
| 02/10/2022 |
CYONANZ
ANDA #207055 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 02/10/2022 |
NYLIA 1/35
ANDA #207056 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 02/10/2022 |
ROFLUMILAST
ANDA #208303 |
ORIG-1 |
ROFLUMILAST |
ZYDUS PHARMS |
|
Approval |
| 02/10/2022 |
AMPHETAMINE SULFATE
ANDA #211139 |
SUPPL-4 |
AMPHETAMINE SULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/10/2022 |
VUMERITY
NDA #211855 |
SUPPL-6 |
DIROXIMEL FUMARATE |
BIOGEN INC |
Labeling |
Approval |
| 02/10/2022 |
AMPHETAMINE SULFATE
ANDA #212619 |
SUPPL-2 |
AMPHETAMINE SULFATE |
GRANULES |
Labeling |
Approval |
| 02/10/2022 |
CLINDAMYCIN PHOSPHATE AND TRETINOIN
ANDA #212845 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE; TRETINOIN |
SOLARIS PHARMA CORP |
|
Approval |
| 02/10/2022 |
FULVESTRANT
ANDA #214682 |
ORIG-1 |
FULVESTRANT |
JIANGSU HANSOH PHARM |
|
Approval |
| 02/10/2022 |
DAPSONE
ANDA #214722 |
ORIG-1 |
DAPSONE |
TORRENT |
|
Approval |
| 02/10/2022 |
ESOMEPRAZOLE SODIUM
ANDA #215732 |
ORIG-1 |
ESOMEPRAZOLE SODIUM |
HAINAN POLY |
|
Approval |
| 02/11/2022 |
HIBICLENS
NDA #017768 |
SUPPL-56 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Labeling |
Approval |
| 02/11/2022 |
ESBRIET
NDA #022535 |
SUPPL-15 |
PIRFENIDONE |
GENENTECH INC |
Labeling |
Approval |
| 02/11/2022 |
PROCYSBI
NDA #203389 |
SUPPL-27 |
CYSTEAMINE BITARTRATE |
HORIZON |
Labeling |
Approval |
| 02/11/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206340 |
SUPPL-5 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/11/2022 |
ESBRIET
NDA #208780 |
SUPPL-5 |
PIRFENIDONE |
GENENTECH INC |
Labeling |
Approval |
| 02/11/2022 |
BRAFTOVI
NDA #210496 |
SUPPL-13 |
ENCORAFENIB |
ARRAY BIOPHARMA INC |
Labeling |
Approval |
| 02/11/2022 |
CLOBAZAM
ANDA #210746 |
SUPPL-1 |
CLOBAZAM |
VISTAPHARM |
Labeling |
Approval |
| 02/11/2022 |
CLOBAZAM
ANDA #211259 |
SUPPL-2 |
CLOBAZAM |
MYLAN |
Labeling |
Approval |
| 02/11/2022 |
TOBRAMYCIN AND DEXAMETHASONE
ANDA #212715 |
ORIG-1 |
DEXAMETHASONE; TOBRAMYCIN |
PADAGIS US |
|
Approval |
| 02/11/2022 |
PROCYSBI
NDA #213491 |
SUPPL-2 |
CYSTEAMINE BITARTRATE |
HORIZON |
Labeling |
Approval |
| 02/11/2022 |
PRAXBIND
BLA #761025 |
SUPPL-13 |
IDARUCIZUMAB |
BOEHRINGER INGELHEIM |
|
Approval |
| 02/14/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422 |
SUPPL-56 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
BARR |
Labeling |
Approval |
| 02/14/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040480 |
SUPPL-25 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/14/2022 |
GAZYVA
BLA #125486 |
SUPPL-29 |
OBINUTUZUMAB |
GENENTECH |
|
Approval |
| 02/14/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #202424 |
SUPPL-5 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/14/2022 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203145 |
SUPPL-26 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 02/14/2022 |
PRASUGREL
ANDA #205888 |
SUPPL-6 |
PRASUGREL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 02/14/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206721 |
SUPPL-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
MYLAN |
Labeling |
Approval |
| 02/14/2022 |
ERYTHROMYCIN LACTOBIONATE
ANDA #215290 |
ORIG-1 |
ERYTHROMYCIN LACTOBIONATE |
NEXUS |
|
Approval |
| 02/15/2022 |
ANCOBON
NDA #017001 |
SUPPL-34 |
FLUCYTOSINE |
BAUSCH |
Labeling |
Approval |
| 02/15/2022 |
GENTAMICIN SULFATE
ANDA #062251 |
SUPPL-30 |
GENTAMICIN SULFATE |
HIKMA |
Labeling |
Approval |
| 02/15/2022 |
TRI-LO-ESTARYLLA
ANDA #091232 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 02/15/2022 |
TRI-LO-ESTARYLLA
ANDA #091232 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM PRESERVATIVE FREE
ANDA #202732 |
SUPPL-13 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM PRESERVATIVE FREE
ANDA #202732 |
SUPPL-14 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #202733 |
SUPPL-11 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #202733 |
SUPPL-13 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #202957 |
SUPPL-13 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #202957 |
SUPPL-16 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #203198 |
SUPPL-12 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
HEPARIN SODIUM
ANDA #203198 |
SUPPL-13 |
HEPARIN SODIUM |
SHENZHEN TECHDOW |
Labeling |
Approval |
| 02/15/2022 |
ICLUSIG
NDA #203469 |
SUPPL-35 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Efficacy |
Approval |
| 02/15/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #204330 |
SUPPL-1 |
DEXTROAMPHETAMINE SULFATE |
NOVEL LABS INC |
Labeling |
Approval |
| 02/15/2022 |
PIPERACILLIN AND TAZOBACTAM
ANDA #204959 |
SUPPL-6 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
SHANDONG |
Labeling |
Approval |
| 02/15/2022 |
TOLVAPTAN
ANDA #206119 |
ORIG-1 |
TOLVAPTAN |
PAR PHARM INC |
|
Approval |
| 02/15/2022 |
VANCOMYCIN HYDROCHLORIDE
ANDA #213059 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
KNACK |
|
Approval |
| 02/16/2022 |
DELESTROGEN
NDA #009402 |
SUPPL-60 |
ESTRADIOL VALERATE |
PAR STERILE PRODUCTS |
Labeling |
Approval |
| 02/16/2022 |
ETHOSUXIMIDE
ANDA #040430 |
SUPPL-19 |
ETHOSUXIMIDE |
BIONPHARMA |
Labeling |
Approval |
| 02/16/2022 |
LEVONEST
ANDA #090719 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/16/2022 |
FERROUS FUMARATE
ANDA #090938 |
SUPPL-2 |
FERROUS FUMARATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
FERROUS FUMARATE
ANDA #090938 |
SUPPL-3 |
FERROUS FUMARATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
FERROUS FUMARATE
ANDA #090938 |
SUPPL-11 |
FERROUS FUMARATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #090938 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #090938 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #090938 |
SUPPL-11 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR LABS INC |
Labeling |
Approval |
| 02/16/2022 |
DASETTA 1/35
ANDA #090948 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/16/2022 |
DASETTA 1/35
ANDA #090948 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/16/2022 |
MARLISSA
ANDA #091452 |
SUPPL-6 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/16/2022 |
MARLISSA
ANDA #091452 |
SUPPL-7 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/16/2022 |
MARLISSA
ANDA #091452 |
SUPPL-8 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/16/2022 |
PRASUGREL
ANDA #205790 |
SUPPL-3 |
PRASUGREL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 02/16/2022 |
FIRVANQ KIT
NDA #208910 |
SUPPL-5 |
VANCOMYCIN HYDROCHLORIDE |
AZURITY |
Labeling |
Approval |
| 02/16/2022 |
MORPHINE SULFATE
ANDA #211454 |
SUPPL-1 |
MORPHINE SULFATE |
WINDER LABS LLC |
Labeling |
Approval |
| 02/16/2022 |
ACCRUFER
NDA #212320 |
SUPPL-11 |
FERRIC MALTOL |
SHIELD TX |
Labeling |
Approval |
| 02/16/2022 |
TROSPIUM CHLORIDE
ANDA #215781 |
ORIG-1 |
TROSPIUM CHLORIDE |
ZAMEER PHARMS |
|
Approval |
| 02/17/2022 |
QUELICIN
NDA #008845 |
SUPPL-79 |
SUCCINYLCHOLINE CHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 02/17/2022 |
QUELICIN PRESERVATIVE FREE
NDA #008845 |
SUPPL-79 |
SUCCINYLCHOLINE CHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 02/17/2022 |
ALOPRIM
NDA #020298 |
SUPPL-12 |
ALLOPURINOL SODIUM |
MYLAN |
Labeling |
Approval |
| 02/17/2022 |
MONODOX
NDA #050641 |
SUPPL-32 |
DOXYCYCLINE |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
| 02/17/2022 |
AVIANE-21
ANDA #075796 |
SUPPL-24 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 02/17/2022 |
AVIANE-28
ANDA #075796 |
SUPPL-24 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DURAMED PHARMS BARR |
Labeling |
Approval |
| 02/17/2022 |
MECLIZINE HYDROCHLORIDE
ANDA #200432 |
ORIG-1 |
MECLIZINE HYDROCHLORIDE |
INVAGEN PHARMS |
|
Approval |
| 02/17/2022 |
MECLIZINE HYDROCHLORIDE
ANDA #200791 |
ORIG-1 |
MECLIZINE HYDROCHLORIDE |
INVAGEN PHARMS |
|
Approval |
| 02/17/2022 |
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473 |
SUPPL-7 |
LINEZOLID |
HOSPIRA |
Labeling |
Approval |
| 02/17/2022 |
CRESEMBA
NDA #207500 |
SUPPL-11 |
ISAVUCONAZONIUM SULFATE |
ASTELLAS |
Labeling |
Approval |
| 02/17/2022 |
CRESEMBA
NDA #207501 |
SUPPL-9 |
ISAVUCONAZONIUM SULFATE |
ASTELLAS |
Labeling |
Approval |
| 02/17/2022 |
EGATEN
NDA #208711 |
SUPPL-2 |
TRICLABENDAZOLE |
NOVARTIS |
Labeling |
Approval |
| 02/17/2022 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #210169 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
MSN |
|
Approval |
| 02/17/2022 |
CLOBETASOL PROPIONATE
ANDA #211240 |
ORIG-1 |
CLOBETASOL PROPIONATE |
QUAGEN |
|
Approval |
| 02/17/2022 |
PYRUKYND
NDA #216196 |
ORIG-1 |
MITAPIVAT SULFATE |
AGIOS PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
| 02/18/2022 |
CONRAY
NDA #013295 |
SUPPL-72 |
IOTHALAMATE MEGLUMINE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
CONRAY 43
NDA #013295 |
SUPPL-72 |
IOTHALAMATE MEGLUMINE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-128
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-200
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-250
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-300
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-370
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-M 200
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-M 300
NDA #018735 |
SUPPL-67 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 12
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 140
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 180
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 210
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 240
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 300
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 350
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 70
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 9
NDA #018956 |
SUPPL-113 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 160
NDA #019710 |
SUPPL-65 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 240
NDA #019710 |
SUPPL-65 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 300
NDA #019710 |
SUPPL-65 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 320
NDA #019710 |
SUPPL-65 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 350
NDA #019710 |
SUPPL-65 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST 150
NDA #020220 |
SUPPL-52 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST 240
NDA #020220 |
SUPPL-52 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST 300
NDA #020220 |
SUPPL-52 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220 |
SUPPL-52 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST 370
NDA #020220 |
SUPPL-52 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
PEPCID AC
NDA #020325 |
SUPPL-37 |
FAMOTIDINE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 02/18/2022 |
ISOVUE-200
NDA #020327 |
SUPPL-23 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-250
NDA #020327 |
SUPPL-23 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-300
NDA #020327 |
SUPPL-23 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
ISOVUE-370
NDA #020327 |
SUPPL-23 |
IOPAMIDOL |
BRACCO |
Labeling |
Approval |
| 02/18/2022 |
VISIPAQUE 270
NDA #020351 |
SUPPL-54 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
VISIPAQUE 320
NDA #020351 |
SUPPL-54 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 240
NDA #020608 |
SUPPL-45 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 300
NDA #020608 |
SUPPL-45 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OMNIPAQUE 350
NDA #020608 |
SUPPL-45 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
VISIPAQUE 270
NDA #020808 |
SUPPL-32 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
VISIPAQUE 320
NDA #020808 |
SUPPL-32 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 240
NDA #020923 |
SUPPL-28 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 300
NDA #020923 |
SUPPL-28 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 320
NDA #020923 |
SUPPL-28 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
OPTIRAY 350
NDA #020923 |
SUPPL-28 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 02/18/2022 |
ULTRAVIST (PHARMACY BULK)
NDA #021425 |
SUPPL-34 |
IOPROMIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 02/18/2022 |
TASIGNA
NDA #022068 |
SUPPL-37 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 02/18/2022 |
BLINCYTO
BLA #125557 |
SUPPL-21 |
BLINATUMOMAB |
AMGEN |
|
Approval |
| 02/18/2022 |
ZYDELIG
NDA #205858 |
SUPPL-16 |
IDELALISIB |
GILEAD SCIENCES INC |
Labeling |
Approval |
| 02/18/2022 |
DARIFENACIN HYDROBROMIDE
ANDA #207664 |
SUPPL-4 |
DARIFENACIN HYDROBROMIDE |
CIPLA |
Labeling |
Approval |
| 02/18/2022 |
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #211013 |
ORIG-1 |
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE |
INVENTIA |
|
Approval |
| 02/18/2022 |
AMANTADINE HYDROCHLORIDE
ANDA #211354 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
| 02/18/2022 |
PREGABALIN
ANDA #212604 |
ORIG-1 |
PREGABALIN |
PATRIN |
|
Approval |
| 02/18/2022 |
CARDIOPLEGIC IN PLASTIC CONTAINER
ANDA #214623 |
ORIG-1 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 02/18/2022 |
NEPHROSCAN
NDA #214993 |
ORIG-1 |
TECHNETIUM TC-99M SUCCIMER |
THERAGNOSTICS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 02/18/2022 |
BETAMETHASONE DIPROPIONATE
ANDA #215186 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
TASMAN PHARMA |
|
Approval |
| 02/18/2022 |
METHYLTESTOSTERONE
ANDA #215270 |
ORIG-1 |
METHYLTESTOSTERONE |
NOVITIUM PHARMA |
|
Approval |
| 02/18/2022 |
BEOVU
BLA #761125 |
SUPPL-10 |
brolucizumab-dbll |
NOVARTIS PHARMS CORP |
|
Approval |
| 02/18/2022 |
BEOVU
BLA #761125 |
SUPPL-12 |
brolucizumab-dbll |
NOVARTIS PHARMS CORP |
|
Approval |
| 02/18/2022 |
BEOVU
BLA #761125 |
SUPPL-13 |
brolucizumab-dbll |
NOVARTIS PHARMS CORP |
|
Approval |
| 02/22/2022 |
TRIVORA-21
ANDA #074538 |
SUPPL-27 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/22/2022 |
TRIVORA-28
ANDA #074538 |
SUPPL-27 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/22/2022 |
ETHOSUXIMIDE
ANDA #200892 |
SUPPL-14 |
ETHOSUXIMIDE |
HERITAGE PHARMS INC |
Labeling |
Approval |
| 02/22/2022 |
LERIBANE
ANDA #203435 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 02/22/2022 |
IBANDRONATE SODIUM
ANDA #204502 |
SUPPL-2 |
IBANDRONATE SODIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 02/22/2022 |
TETRACAINE HYDROCHLORIDE
NDA #210821 |
SUPPL-5 |
TETRACAINE HYDROCHLORIDE |
BAUSCH LOMB IRELAND |
Labeling |
Approval |
| 02/22/2022 |
METFORMIN HYDROCHLORIDE
ANDA #214629 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 02/23/2022 |
AMBIEN
NDA #019908 |
SUPPL-40 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
AMBIEN
NDA #019908 |
SUPPL-44 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
AMBIEN
NDA #019908 |
SUPPL-47 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
CUBICIN
NDA #021572 |
SUPPL-68 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
| 02/23/2022 |
CUBICIN RF
NDA #021572 |
SUPPL-68 |
DAPTOMYCIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
| 02/23/2022 |
AMBIEN CR
NDA #021774 |
SUPPL-21 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
AMBIEN CR
NDA #021774 |
SUPPL-25 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
AMBIEN CR
NDA #021774 |
SUPPL-28 |
ZOLPIDEM TARTRATE |
SANOFI AVENTIS US |
Labeling |
Approval |
| 02/23/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #076626 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 02/23/2022 |
NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #076627 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
WATSON LABS |
Labeling |
Approval |
| 02/23/2022 |
LINEZOLID
ANDA #205517 |
SUPPL-4 |
LINEZOLID |
ALKEM LABS LTD |
Labeling |
Approval |
| 02/23/2022 |
BONJESTA
NDA #209661 |
SUPPL-7 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
DUCHESNAY |
Manufacturing (CMC) |
Approval |
| 02/23/2022 |
ALIQOPA
NDA #209936 |
SUPPL-10 |
COPANLISIB DIHYDROCHLORIDE |
BAYER HEALTHCARE |
Labeling |
Approval |
| 02/23/2022 |
APOMORPHINE HYDROCHLORIDE
ANDA #212025 |
ORIG-1 |
APOMORPHINE HYDROCHLORIDE |
SAGE CHEMS |
|
Approval |
| 02/23/2022 |
SUCCINYLCHOLINE CHLORIDE
ANDA #214246 |
SUPPL-2 |
SUCCINYLCHOLINE CHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 02/23/2022 |
DEFERASIROX
ANDA #215026 |
ORIG-1 |
DEFERASIROX |
CIPLA |
|
Approval |
| 02/23/2022 |
ACETYLCYSTEINE
ANDA #215620 |
ORIG-1 |
ACETYLCYSTEINE |
INDOCO |
|
Approval |
| 02/23/2022 |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #216211 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; TRIAMTERENE |
RUBICON |
|
Approval |
| 02/23/2022 |
CABLIVI
BLA #761112 |
SUPPL-9 |
CAPLACIZUMAB-YHDP |
ABLYNX NV |
|
Approval |
| 02/24/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #070687 |
SUPPL-43 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS TEVA |
Labeling |
Approval |
| 02/24/2022 |
NORETHIN 1/35E-28
ANDA #071481 |
SUPPL-15 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 02/24/2022 |
CEFAZOLIN SODIUM
ANDA #203661 |
SUPPL-6 |
CEFAZOLIN SODIUM |
QILU |
Labeling |
Approval |
| 02/24/2022 |
JARDIANCE
NDA #204629 |
SUPPL-33 |
EMPAGLIFLOZIN |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
| 02/24/2022 |
ATORVASTATIN CALCIUM
ANDA #206536 |
SUPPL-7 |
ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/24/2022 |
ATORVASTATIN CALCIUM
ANDA #206536 |
SUPPL-8 |
ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/24/2022 |
ATORVASTATIN CALCIUM
ANDA #206536 |
SUPPL-10 |
ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/24/2022 |
ATORVASTATIN CALCIUM
ANDA #206536 |
SUPPL-11 |
ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/24/2022 |
OCALIVA
NDA #207999 |
SUPPL-8 |
OBETICHOLIC ACID |
INTERCEPT PHARMS INC |
Labeling |
Approval |
| 02/24/2022 |
EPIDIOLEX
NDA #210365 |
SUPPL-15 |
CANNABIDIOL |
JAZZ PHARMS RES |
Labeling |
Approval |
| 02/24/2022 |
CHLORTHALIDONE
ANDA #212875 |
ORIG-1 |
CHLORTHALIDONE |
TAGI |
|
Approval |
| 02/24/2022 |
CHLORTHALIDONE
ANDA #212878 |
ORIG-1 |
CHLORTHALIDONE |
TAGI |
|
Approval |
| 02/24/2022 |
NORLIQVA
NDA #214439 |
ORIG-1 |
AMLODIPINE BESYLATE |
CMP DEV LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 02/24/2022 |
ENALAPRIL MALEATE
ANDA #214467 |
ORIG-1 |
ENALAPRIL MALEATE |
ANNORA PHARMA |
|
Approval |
| 02/25/2022 |
DESOXYN
NDA #005378 |
SUPPL-37 |
METHAMPHETAMINE HYDROCHLORIDE |
AJENAT PHARMS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 10
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 12.5
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 15
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 20
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 30
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 5
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL 7.5
NDA #011522 |
SUPPL-44 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TEVA WOMENS |
Labeling |
Approval |
| 02/25/2022 |
DEXEDRINE
NDA #017078 |
SUPPL-54 |
DEXTROAMPHETAMINE SULFATE |
IMPAX LABS INC |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 10
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 15
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 20
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 25
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 30
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ADDERALL XR 5
NDA #021303 |
SUPPL-36 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
VYVANSE
NDA #021977 |
SUPPL-48 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
MYDAYIS
NDA #022063 |
SUPPL-3 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
ACUVUE THERAVISION WITH KETOTIFEN
NDA #022388 |
ORIG-1 |
KETOTIFEN FUMARATE |
JOHNSON JOHNSON VISN |
Type 3 - New Dosage Form and Type 4 - New Combination |
Approval |
| 02/25/2022 |
ACUVUE THERAVISION WITH KETOTIFEN
NDA #022388 |
SUPPL-1 |
KETOTIFEN FUMARATE |
JOHNSON JOHNSON VISN |
Type 3 - New Dosage Form |
Approval |
| 02/25/2022 |
METAXALONE
NDA #022503 |
SUPPL-1 |
METAXALONE |
PRIMUS PHARMS |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #040299 |
SUPPL-4 |
DEXTROAMPHETAMINE SULFATE |
STRIDES PHARMA |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #040361 |
SUPPL-30 |
DEXTROAMPHETAMINE SULFATE |
BARR |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040422 |
SUPPL-57 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
BARR |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #040436 |
SUPPL-22 |
DEXTROAMPHETAMINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040439 |
SUPPL-29 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040440 |
SUPPL-26 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444 |
SUPPL-24 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444 |
SUPPL-32 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444 |
SUPPL-33 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040480 |
SUPPL-32 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #040776 |
SUPPL-6 |
DEXTROAMPHETAMINE SULFATE |
PRASCO |
Labeling |
Approval |
| 02/25/2022 |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #071851 |
SUPPL-37 |
HYDROCHLOROTHIAZIDE; TRIAMTERENE |
WATSON LABS |
Labeling |
Approval |
| 02/25/2022 |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
ANDA #073449 |
SUPPL-25 |
HYDROCHLOROTHIAZIDE; TRIAMTERENE |
WATSON LABS |
Labeling |
Approval |
| 02/25/2022 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #076393 |
SUPPL-7 |
ETHINYL ESTRADIOL; NORETHINDRONE |
WATSON LABS |
Labeling |
Approval |
| 02/25/2022 |
PAROXETINE HYDROCHLORIDE
ANDA #077584 |
SUPPL-34 |
PAROXETINE HYDROCHLORIDE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
PAROXETINE HYDROCHLORIDE
ANDA #077584 |
SUPPL-35 |
PAROXETINE HYDROCHLORIDE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #083901 |
SUPPL-6 |
AMPHETAMINE SULFATE |
LANNETT |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #083903 |
SUPPL-29 |
DEXTROAMPHETAMINE SULFATE |
LANNETT |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #085652 |
SUPPL-6 |
DEXTROAMPHETAMINE SULFATE |
LANNETT |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #090533 |
SUPPL-11 |
DEXTROAMPHETAMINE SULFATE |
AZURITY |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #090652 |
SUPPL-7 |
DEXTROAMPHETAMINE SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
YERVOY
BLA #125377 |
SUPPL-126 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 02/25/2022 |
YERVOY
BLA #125377 |
SUPPL-127 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 02/25/2022 |
OPDIVO
BLA #125554 |
SUPPL-109 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 02/25/2022 |
EVEKEO
ANDA #200166 |
SUPPL-9 |
AMPHETAMINE SULFATE |
AZURITY |
Labeling |
Approval |
| 02/25/2022 |
CYSTARAN
NDA #200740 |
SUPPL-3 |
CYSTEAMINE HYDROCHLORIDE |
LEADIANT BIOSCI INC |
Manufacturing (CMC) |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #202424 |
SUPPL-7 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #202893 |
SUPPL-4 |
DEXTROAMPHETAMINE SULFATE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #203548 |
SUPPL-6 |
DEXTROAMPHETAMINE SULFATE |
AVANTHI INC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #203644 |
SUPPL-9 |
DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
ADZENYS ER
NDA #204325 |
SUPPL-3 |
AMPHETAMINE |
NEOS THERAPS INC |
Labeling |
Approval |
| 02/25/2022 |
ADZENYS XR-ODT
NDA #204326 |
SUPPL-8 |
AMPHETAMINE |
NEOS THERAPS |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #204330 |
SUPPL-2 |
DEXTROAMPHETAMINE SULFATE |
NOVEL LABS INC |
Labeling |
Approval |
| 02/25/2022 |
NUVESSA
NDA #205223 |
SUPPL-6 |
METRONIDAZOLE |
CHEMO RESEARCH SL |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206340 |
SUPPL-6 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206721 |
SUPPL-3 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
MYLAN |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #207340 |
SUPPL-3 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #207388 |
SUPPL-3 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ALVOGEN |
Labeling |
Approval |
| 02/25/2022 |
DYANAVEL XR
NDA #208147 |
SUPPL-13 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
VYVANSE
NDA #208510 |
SUPPL-5 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #209799 |
SUPPL-2 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
NUVO PHARM |
Labeling |
Approval |
| 02/25/2022 |
EVEKEO ODT
NDA #209905 |
SUPPL-2 |
AMPHETAMINE SULFATE |
AZURITY |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #210059 |
SUPPL-2 |
DEXTROAMPHETAMINE SULFATE |
NUVO PHARM |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #210293 |
SUPPL-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
USPHARMA WINDLAS |
Labeling |
Approval |
| 02/25/2022 |
DYANAVEL XR 10
NDA #210526 |
SUPPL-3 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
DYANAVEL XR 15
NDA #210526 |
SUPPL-3 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
DYANAVEL XR 20
NDA #210526 |
SUPPL-3 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
DYANAVEL XR 5
NDA #210526 |
SUPPL-3 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Labeling |
Approval |
| 02/25/2022 |
ARAKODA
NDA #210607 |
SUPPL-2 |
TAFENOQUINE SUCCINATE |
60 DEGREES PHARMS |
Manufacturing (CMC) |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #211139 |
SUPPL-5 |
AMPHETAMINE SULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211352 |
SUPPL-7 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ELITE LABS INC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #211639 |
SUPPL-2 |
AMPHETAMINE SULFATE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #211861 |
SUPPL-1 |
AMPHETAMINE SULFATE |
PRINSTON INC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMPHETAMINE SULFATE
ANDA #212160 |
SUPPL-1 |
DEXTROAMPHETAMINE SULFATE |
WINDER LABS LLC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #212186 |
SUPPL-1 |
AMPHETAMINE SULFATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #212582 |
SUPPL-1 |
AMPHETAMINE SULFATE |
CEROVENE INC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #212619 |
SUPPL-4 |
AMPHETAMINE SULFATE |
GRANULES |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #212901 |
SUPPL-1 |
AMPHETAMINE SULFATE |
SENORES PHARMS |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #212919 |
SUPPL-3 |
AMPHETAMINE SULFATE |
BIONPHARMA |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #213111 |
SUPPL-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
RHODES PHARMS |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213583 |
SUPPL-2 |
AMPHETAMINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
| 02/25/2022 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #213709 |
SUPPL-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ASCENT PHARMS INC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213720 |
SUPPL-1 |
AMPHETAMINE SULFATE |
ALKEM LABS LTD |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213763 |
SUPPL-1 |
AMPHETAMINE SULFATE |
NOVAST LABS |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213852 |
SUPPL-1 |
AMPHETAMINE SULFATE |
RHODES PHARMS |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213898 |
SUPPL-1 |
AMPHETAMINE SULFATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #213980 |
SUPPL-1 |
AMPHETAMINE SULFATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 02/25/2022 |
AMPHETAMINE SULFATE
ANDA #214574 |
SUPPL-1 |
AMPHETAMINE SULFATE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 02/25/2022 |
DIVALPROEX SODIUM
ANDA #214643 |
ORIG-1 |
DIVALPROEX SODIUM |
UNICHEM |
|
Approval |
| 02/25/2022 |
EPHEDRINE SULFATE
ANDA #216146 |
ORIG-1 |
EPHEDRINE SULFATE |
GLAND PHARMA LTD |
|
Approval |
| 02/25/2022 |
CARBON DIOXIDE, USP
NDA #217082 |
ORIG-1 |
CARBON DIOXIDE |
CONTINENTAL CARBONIC PRODUCTS, INC. |
|
Approval |
| 02/25/2022 |
RELEUKO
BLA #761082 |
ORIG-1 |
FILGRASTIM-AYOW |
KASHIV BIOSCIENCES LLC |
|
Approval |
| 02/28/2022 |
FLUOROPLEX
NDA #016988 |
SUPPL-33 |
FLUOROURACIL |
CHARTWELL RX |
Labeling |
Approval |
| 02/28/2022 |
AKTEN
NDA #022221 |
SUPPL-8 |
LIDOCAINE HYDROCHLORIDE |
THEA PHARMA |
Labeling |
Approval |
| 02/28/2022 |
LOW-OGESTREL-21
ANDA #075288 |
SUPPL-23 |
ETHINYL ESTRADIOL; NORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/28/2022 |
LOW-OGESTREL-28
ANDA #075288 |
SUPPL-23 |
ETHINYL ESTRADIOL; NORGESTREL |
DR REDDYS LABS SA |
Labeling |
Approval |
| 02/28/2022 |
OMEPRAZOLE
ANDA #076048 |
SUPPL-26 |
OMEPRAZOLE |
APOTEX |
Labeling |
Approval |
| 02/28/2022 |
WERA
ANDA #091204 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/28/2022 |
WERA
ANDA #091204 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 02/28/2022 |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091539 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
WATSON LABS INC |
Labeling |
Approval |
| 02/28/2022 |
ACTEMRA
BLA #125276 |
SUPPL-134 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 02/28/2022 |
MYALEPT
BLA #125390 |
SUPPL-24 |
METRELEPTIN |
AMRYT |
|
Approval |
| 02/28/2022 |
ACTEMRA
BLA #125472 |
SUPPL-46 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 02/28/2022 |
IRBESARTAN
ANDA #202910 |
SUPPL-15 |
IRBESARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
| 02/28/2022 |
ONDANSETRON HYDROCHLORIDE
ANDA #203711 |
SUPPL-13 |
ONDANSETRON HYDROCHLORIDE |
QILU PHARM HAINAN |
Labeling |
Approval |
| 02/28/2022 |
CELECOXIB
ANDA #205129 |
SUPPL-1 |
CELECOXIB |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 02/28/2022 |
BORTEZOMIB
NDA #206927 |
SUPPL-2 |
BORTEZOMIB |
DR REDDYS |
Labeling |
Approval |
| 02/28/2022 |
TETRACAINE HYDROCHLORIDE
NDA #208135 |
SUPPL-5 |
TETRACAINE HYDROCHLORIDE |
ALCON LABS |
Labeling |
Approval |
| 02/28/2022 |
CYTARABINE
ANDA #208485 |
ORIG-1 |
CYTARABINE |
MEITHEAL |
|
Approval |
| 02/28/2022 |
VONJO
NDA #208712 |
ORIG-1 |
PACRITINIB CITRATE |
CTI BIOPHARMA CORP |
Type 1 - New Molecular Entity |
Approval |
| 02/28/2022 |
ALUNBRIG
NDA #208772 |
SUPPL-13 |
BRIGATINIB |
TAKEDA PHARMS USA |
Efficacy |
Approval |
| 02/28/2022 |
DICLOFENAC SODIUM
ANDA #209484 |
SUPPL-2 |
DICLOFENAC SODIUM |
HIKMA |
Labeling |
Approval |
| 02/28/2022 |
OSELTAMIVIR PHOSPHATE
ANDA #214949 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
CHEMISTRY HLTH |
|
Approval |
| 02/28/2022 |
THIOTHIXENE
ANDA #215456 |
ORIG-1 |
THIOTHIXENE |
AMNEAL |
|
Approval |
| 02/28/2022 |
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
NDA #215457 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
KALEO INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 02/28/2022 |
ASPRUZYO SPRINKLE
NDA #216018 |
ORIG-1 |
RANOLAZINE |
SPIL |
Type 3 - New Dosage Form |
Approval |
