11/01/2021 |
AZULFIDINE NDA #007073 |
SUPPL-130 |
SULFASALAZINE |
PFIZER |
Labeling |
Approval |
11/01/2021 |
AZULFIDINE EN-TABS NDA #007073 |
SUPPL-130 |
SULFASALAZINE |
PFIZER |
Labeling |
Approval |
11/01/2021 |
ROWASA NDA #019618 |
SUPPL-29 |
MESALAMINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
11/01/2021 |
SFROWASA NDA #019618 |
SUPPL-29 |
MESALAMINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
11/01/2021 |
DIPENTUM NDA #019715 |
SUPPL-30 |
OLSALAZINE SODIUM |
MYLAN SPCLT VIATRIS |
Labeling |
Approval |
11/01/2021 |
PENTASA NDA #020049 |
SUPPL-36 |
MESALAMINE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/01/2021 |
COLAZAL NDA #020610 |
SUPPL-24 |
BALSALAZIDE DISODIUM |
VALEANT PHARMS INTL |
Labeling |
Approval |
11/01/2021 |
CANASA NDA #021252 |
SUPPL-28 |
MESALAMINE |
ABBVIE |
Labeling |
Approval |
11/01/2021 |
FINACEA NDA #021470 |
SUPPL-17 |
AZELAIC ACID |
LEO PHARMA AS |
Labeling |
Approval |
11/01/2021 |
ASACOL HD NDA #021830 |
SUPPL-19 |
MESALAMINE |
ABBVIE |
Labeling |
Approval |
11/01/2021 |
LIALDA NDA #022000 |
SUPPL-23 |
MESALAMINE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/01/2021 |
GIAZO NDA #022205 |
SUPPL-5 |
BALSALAZIDE DISODIUM |
VALEANT PHARMS INTL |
Labeling |
Approval |
11/01/2021 |
APRISO NDA #022301 |
SUPPL-18 |
MESALAMINE |
SALIX |
Labeling |
Approval |
11/01/2021 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202842 |
SUPPL-8 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
PAR PHARM INC |
Labeling |
Approval |
11/01/2021 |
DELZICOL NDA #204412 |
SUPPL-15 |
MESALAMINE |
ABBVIE |
Labeling |
Approval |
11/01/2021 |
SAVAYSA NDA #206316 |
SUPPL-18 |
EDOXABAN TOSYLATE |
DAIICHI SANKYO INC |
Labeling |
Approval |
11/01/2021 |
QUETIAPINE FUMARATE ANDA #207655 |
SUPPL-5 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/01/2021 |
QUETIAPINE FUMARATE ANDA #207655 |
SUPPL-6 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/01/2021 |
QUETIAPINE FUMARATE ANDA #207655 |
SUPPL-7 |
QUETIAPINE FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/01/2021 |
ACYCLOVIR ANDA #208766 |
SUPPL-2 |
ACYCLOVIR |
AMNEAL |
Labeling |
Approval |
11/01/2021 |
ASTEPRO ALLERGY NDA #213872 |
SUPPL-1 |
AZELASTINE HYDROCHLORIDE |
BAYER HLTHCARE |
Manufacturing (CMC) |
Approval |
11/01/2021 |
CHILDREN'S ASTEPRO ALLERGY NDA #213872 |
SUPPL-1 |
AZELASTINE HYDROCHLORIDE |
BAYER HLTHCARE |
Manufacturing (CMC) |
Approval |
11/01/2021 |
DROXIDOPA ANDA #215265 |
ORIG-1 |
DROXIDOPA |
SLATE RUN PHARMA |
|
Approval |
11/02/2021 |
VYVANSE NDA #021977 |
SUPPL-47 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/02/2021 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077565 |
SUPPL-14 |
ZIPRASIDONE HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/02/2021 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077565 |
SUPPL-18 |
ZIPRASIDONE HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/02/2021 |
DISULFIRAM ANDA #091563 |
SUPPL-7 |
DISULFIRAM |
CHARTWELL MOLECULES |
Manufacturing (CMC) |
Approval |
11/02/2021 |
ONCASPAR BLA #103411 |
SUPPL-5201 |
PEGASPARGASE |
SIGMA TAU |
|
Approval |
11/02/2021 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-9 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
11/02/2021 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-11 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
11/02/2021 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-12 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
11/02/2021 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-13 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
11/02/2021 |
QUETIAPINE FUMARATE ANDA #202674 |
SUPPL-16 |
QUETIAPINE FUMARATE |
UNICHEM |
Labeling |
Approval |
11/02/2021 |
VYVANSE NDA #208510 |
SUPPL-4 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/02/2021 |
ACYCLOVIR ANDA #208702 |
SUPPL-2 |
ACYCLOVIR |
PADAGIS ISRAEL |
Labeling |
Approval |
11/02/2021 |
PAROXETINE HYDROCHLORIDE ANDA #211248 |
ORIG-1 |
PAROXETINE HYDROCHLORIDE |
YILING |
|
Approval |
11/02/2021 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE ANDA #211476 |
ORIG-1 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
TEVA PHARMS USA |
|
Approval |
11/02/2021 |
LEVOLEUCOVORIN CALCIUM ANDA #213797 |
ORIG-1 |
LEVOLEUCOVORIN CALCIUM |
AILEX PHARMS LLC |
|
Approval |
11/02/2021 |
VALSARTAN ANDA #214102 |
ORIG-1 |
VALSARTAN |
NOVITIUM PHARMA |
|
Approval |
11/02/2021 |
MYCOPHENOLATE MOFETIL ANDA #214871 |
ORIG-1 |
MYCOPHENOLATE MOFETIL |
AMNEAL |
|
Approval |
11/03/2021 |
LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019632 |
SUPPL-50 |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Labeling |
Approval |
11/03/2021 |
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019634 |
SUPPL-50 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Labeling |
Approval |
11/03/2021 |
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019634 |
SUPPL-50 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Labeling |
Approval |
11/03/2021 |
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER NDA #019634 |
SUPPL-50 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
B BRAUN |
Labeling |
Approval |
11/03/2021 |
RINGER'S IN PLASTIC CONTAINER NDA #020002 |
SUPPL-32 |
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
11/03/2021 |
EXCEDRIN (MIGRAINE RELIEF) NDA #020802 |
SUPPL-38 |
ACETAMINOPHEN; ASPIRIN; CAFFEINE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/03/2021 |
ZYRTEC-D 12 HOUR NDA #021150 |
SUPPL-21 |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
11/03/2021 |
CITANEST FORTE DENTAL NDA #021383 |
SUPPL-10 |
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
11/03/2021 |
ROZEREM NDA #021782 |
SUPPL-22 |
RAMELTEON |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/03/2021 |
VOLTAREN ARTHRITIS PAIN NDA #022122 |
SUPPL-18 |
DICLOFENAC SODIUM |
HALEON US HOLDINGS |
Labeling |
Approval |
11/03/2021 |
FLECAINIDE ACETATE ANDA #075882 |
SUPPL-13 |
FLECAINIDE ACETATE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
11/03/2021 |
BETASERON BLA #103471 |
SUPPL-5200 |
INTERFERON BETA-1B |
BAYER HEALTHCARE PHARMS |
|
Approval |
11/03/2021 |
AVONEX BLA #103628 |
SUPPL-5266 |
INTERFERON BETA-1A |
BIOGEN |
|
Approval |
11/03/2021 |
REBIF BLA #103780 |
SUPPL-5210 |
INTERFERON BETA-1A |
SERONO INC |
|
Approval |
11/03/2021 |
PLEGRIDY BLA #125499 |
SUPPL-23 |
PEGINTERFERON BETA-1A |
BIOGEN IDEC INC |
|
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-3 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-5 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-6 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-7 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-8 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-9 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-11 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
OLANZAPINE ANDA #203708 |
SUPPL-13 |
OLANZAPINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/03/2021 |
ISOSULFAN BLUE ANDA #213130 |
ORIG-1 |
ISOSULFAN BLUE |
MEITHEAL |
|
Approval |
11/03/2021 |
GATIFLOXACIN ANDA #213542 |
ORIG-1 |
GATIFLOXACIN |
TORRENT |
|
Approval |
11/03/2021 |
MYCOPHENOLIC SODIUM ANDA #214289 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
TWI PHARMS |
|
Approval |
11/03/2021 |
FAMOTIDINE ANDA #216030 |
ORIG-1 |
FAMOTIDINE |
ASCENT PHARMS INC |
|
Approval |
11/04/2021 |
VELCADE NDA #021602 |
SUPPL-46 |
BORTEZOMIB |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/04/2021 |
BYETTA NDA #021773 |
SUPPL-45 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Efficacy |
Approval |
11/04/2021 |
SALONPAS NDA #022029 |
SUPPL-19 |
MENTHOL; METHYL SALICYLATE |
HISAMITSU PHARM CO |
Labeling |
Approval |
11/04/2021 |
JANUMET NDA #022044 |
SUPPL-51 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
11/04/2021 |
JANUMET XR NDA #202270 |
SUPPL-25 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
11/04/2021 |
DYANAVEL XR 10 NDA #210526 |
ORIG-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Type 3 - New Dosage Form |
Approval |
11/04/2021 |
DYANAVEL XR 15 NDA #210526 |
ORIG-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Type 3 - New Dosage Form |
Approval |
11/04/2021 |
DYANAVEL XR 20 NDA #210526 |
ORIG-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Type 3 - New Dosage Form |
Approval |
11/04/2021 |
DYANAVEL XR 5 NDA #210526 |
ORIG-1 |
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE |
TRIS PHARMA INC |
Type 3 - New Dosage Form |
Approval |
11/04/2021 |
YUPELRI NDA #210598 |
SUPPL-2 |
REVEFENACIN |
MYLAN IRELAND LTD |
Labeling |
Approval |
11/04/2021 |
HYDROCORTISONE VALERATE ANDA #211047 |
ORIG-1 |
HYDROCORTISONE VALERATE |
ENCUBE ETHICALS |
|
Approval |
11/04/2021 |
PREGABALIN ANDA #211967 |
ORIG-1 |
PREGABALIN |
MYLAN |
|
Approval |
11/04/2021 |
YUTREPIA NDA #213005 |
ORIG-1 |
TREPROSTINIL |
Liquidia Technologies, Inc. |
Type 3 - New Dosage Form |
Tentative Approval |
11/04/2021 |
TADALAFIL ANDA #215556 |
ORIG-1 |
TADALAFIL |
VKT PHARMA |
|
Approval |
11/04/2021 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE ANDA #215562 |
ORIG-1 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
NOVITIUM PHARMA |
|
Approval |
11/04/2021 |
FAMOTIDINE ANDA #215767 |
ORIG-1 |
FAMOTIDINE |
ANNORA PHARMA |
|
Approval |
11/05/2021 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #206734 |
ORIG-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SUN PHARM INDS INC |
|
Approval |
11/05/2021 |
ROZLYTREK NDA #212725 |
SUPPL-5 |
ENTRECTINIB |
GENENTECH INC |
Labeling |
Approval |
11/05/2021 |
EPRONTIA NDA #214679 |
ORIG-1 |
TOPIRAMATE |
AZURITY |
Type 3 - New Dosage Form |
Approval |
11/08/2021 |
AMNESTEEM ANDA #075945 |
SUPPL-41 |
ISOTRETINOIN |
MYLAN PHARMS INC |
Labeling |
Approval |
11/08/2021 |
CLARAVIS ANDA #076135 |
SUPPL-53 |
ISOTRETINOIN |
TEVA PHARMS USA |
Labeling |
Approval |
11/08/2021 |
CLARAVIS ANDA #076356 |
SUPPL-48 |
ISOTRETINOIN |
TEVA PHARMS USA |
Labeling |
Approval |
11/08/2021 |
MYORISAN ANDA #076485 |
SUPPL-28 |
ISOTRETINOIN |
UPSHER SMITH LABS |
Labeling |
Approval |
11/08/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #200837 |
SUPPL-12 |
VANCOMYCIN HYDROCHLORIDE |
SAGENT PHARMS |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #201749 |
SUPPL-3 |
METHOTREXATE SODIUM |
SUN PHARM |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #201749 |
SUPPL-6 |
METHOTREXATE SODIUM |
SUN PHARM |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #201749 |
SUPPL-10 |
METHOTREXATE SODIUM |
SUN PHARM |
Labeling |
Approval |
11/08/2021 |
AZTREONAM ANDA #206517 |
ORIG-1 |
AZTREONAM |
HOSPIRA |
|
Approval |
11/08/2021 |
TRANEXAMIC ACID ANDA #206594 |
SUPPL-4 |
TRANEXAMIC ACID |
EPIC PHARMA LLC |
Labeling |
Approval |
11/08/2021 |
ISOTRETINOIN ANDA #207792 |
SUPPL-15 |
ISOTRETINOIN |
AMNEAL PHARMS NY |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #207812 |
SUPPL-2 |
METHOTREXATE SODIUM |
ZYDUS PHARMS |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #207812 |
SUPPL-4 |
METHOTREXATE SODIUM |
ZYDUS PHARMS |
Labeling |
Approval |
11/08/2021 |
CLOBAZAM ANDA #208825 |
SUPPL-2 |
CLOBAZAM |
BIONPHARMA |
Labeling |
Approval |
11/08/2021 |
MAGNESIUM SULFATE IN PLASTIC CONTAINER ANDA #209642 |
ORIG-1 |
MAGNESIUM SULFATE |
MILLA PHARMS |
|
Approval |
11/08/2021 |
CLOBAZAM ANDA #209687 |
SUPPL-5 |
CLOBAZAM |
UPSHER SMITH LABS |
Labeling |
Approval |
11/08/2021 |
CLOBAZAM ANDA #211959 |
SUPPL-1 |
CLOBAZAM |
CELLTRION |
Labeling |
Approval |
11/08/2021 |
CLOBAZAM ANDA #212398 |
SUPPL-1 |
CLOBAZAM |
ACCORD HLTHCARE |
Labeling |
Approval |
11/08/2021 |
METHOTREXATE SODIUM ANDA #213343 |
SUPPL-1 |
METHOTREXATE SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
11/08/2021 |
METOPROLOL SUCCINATE ANDA #213854 |
SUPPL-1 |
METOPROLOL SUCCINATE |
YICHANG HUMANWELL |
Manufacturing (CMC) |
Approval |
11/08/2021 |
LIDOCAINE HYDROCHLORIDE ANDA #214336 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
ASPIRO |
|
Approval |
11/08/2021 |
LIDOCAINE HYDROCHLORIDE ANDA #214339 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
ASPIRO |
|
Approval |
11/08/2021 |
LINCOMYCIN HYDROCHLORIDE ANDA #215082 |
ORIG-1 |
LINCOMYCIN HYDROCHLORIDE |
MICRO LABS |
|
Approval |
11/08/2021 |
FAMOTIDINE ANDA #215766 |
ORIG-1 |
FAMOTIDINE |
ANNORA PHARMA |
|
Approval |
11/09/2021 |
PRINIVIL NDA #019558 |
SUPPL-63 |
LISINOPRIL |
MERCK |
Labeling |
Approval |
11/09/2021 |
PROCARDIA XL NDA #019684 |
SUPPL-33 |
NIFEDIPINE |
PFIZER |
Labeling |
Approval |
11/09/2021 |
NICORETTE NDA #021330 |
SUPPL-24 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/09/2021 |
DIAZEPAM ANDA #070313 |
SUPPL-25 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
11/09/2021 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #076629 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
DR REDDYS LABS SA |
Labeling |
Approval |
11/09/2021 |
MEMANTINE HYDROCHLORIDE ANDA #200155 |
SUPPL-1 |
MEMANTINE HYDROCHLORIDE |
TORRENT |
Labeling |
Approval |
11/09/2021 |
ARFORMOTEROL TARTRATE ANDA #200293 |
ORIG-1 |
ARFORMOTEROL TARTRATE |
TEVA PHARMS USA |
|
Approval |
11/09/2021 |
LAMOTRIGINE ANDA #201791 |
SUPPL-8 |
LAMOTRIGINE |
PAR PHARM |
Labeling |
Approval |
11/09/2021 |
ZENATANE ANDA #202099 |
SUPPL-23 |
ISOTRETINOIN |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/09/2021 |
TRANEXAMIC ACID ANDA #202373 |
SUPPL-2 |
TRANEXAMIC ACID |
EPIC PHARMA LLC |
Labeling |
Approval |
11/09/2021 |
LAMOTRIGINE ANDA #202383 |
SUPPL-12 |
LAMOTRIGINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/09/2021 |
LAMOTRIGINE ANDA #202383 |
SUPPL-13 |
LAMOTRIGINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/09/2021 |
QUETIAPINE FUMARATE ANDA #203150 |
SUPPL-3 |
QUETIAPINE FUMARATE |
JUBILANT GENERICS |
Labeling |
Approval |
11/09/2021 |
QUETIAPINE FUMARATE ANDA #203150 |
SUPPL-8 |
QUETIAPINE FUMARATE |
JUBILANT GENERICS |
Labeling |
Approval |
11/09/2021 |
QUETIAPINE FUMARATE ANDA #203150 |
SUPPL-10 |
QUETIAPINE FUMARATE |
JUBILANT GENERICS |
Labeling |
Approval |
11/09/2021 |
QUETIAPINE FUMARATE ANDA #203359 |
SUPPL-14 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/09/2021 |
QUETIAPINE FUMARATE ANDA #203359 |
SUPPL-15 |
QUETIAPINE FUMARATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/09/2021 |
LAMOTRIGINE ANDA #203370 |
SUPPL-13 |
LAMOTRIGINE |
TORRENT |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-2 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-5 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-6 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-7 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-10 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
LANSOPRAZOLE ANDA #203957 |
SUPPL-12 |
LANSOPRAZOLE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/09/2021 |
TRANEXAMIC ACID ANDA #209860 |
SUPPL-1 |
TRANEXAMIC ACID |
APOTEX |
Labeling |
Approval |
11/09/2021 |
TRANEXAMIC ACID ANDA #209860 |
SUPPL-2 |
TRANEXAMIC ACID |
APOTEX |
Labeling |
Approval |
11/09/2021 |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER ANDA #211428 |
ORIG-1 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS KABI USA |
|
Approval |
11/09/2021 |
TESTOSTERONE ANDA #212984 |
ORIG-1 |
TESTOSTERONE |
ENCUBE |
|
Approval |
11/09/2021 |
GLYCOPYRROLATE ANDA #214213 |
ORIG-1 |
GLYCOPYRROLATE |
ZYDUS PHARMS |
|
Approval |
11/10/2021 |
CLOZARIL NDA #019758 |
SUPPL-99 |
CLOZAPINE |
HERITAGE LIFE |
REMS |
Approval |
11/10/2021 |
EFFEXOR XR NDA #020699 |
SUPPL-113 |
VENLAFAXINE HYDROCHLORIDE |
UPJOHN |
Labeling |
Approval |
11/10/2021 |
ZYVOX NDA #021131 |
SUPPL-40 |
LINEZOLID |
PFIZER |
Labeling |
Approval |
11/10/2021 |
PRISTIQ NDA #021992 |
SUPPL-47 |
DESVENLAFAXINE SUCCINATE |
PF PRISM CV |
Labeling |
Approval |
11/10/2021 |
DIAZEPAM ANDA #070312 |
SUPPL-18 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
11/10/2021 |
CLOZAPINE ANDA #074949 |
SUPPL-86 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
11/10/2021 |
MIDAZOLAM HYDROCHLORIDE ANDA #075243 |
SUPPL-36 |
MIDAZOLAM HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/10/2021 |
CLOZAPINE ANDA #075417 |
SUPPL-51 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #075713 |
SUPPL-55 |
CLOZAPINE |
SUN PHARM INDS INC |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #076809 |
SUPPL-49 |
CLOZAPINE |
IVAX SUB TEVA PHARMS |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #090308 |
SUPPL-11 |
CLOZAPINE |
BARR LABS INC |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #201824 |
SUPPL-16 |
CLOZAPINE |
MYLAN |
REMS |
Approval |
11/10/2021 |
LEVETIRACETAM ANDA #202095 |
SUPPL-3 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
11/10/2021 |
LEVETIRACETAM ANDA #202095 |
SUPPL-5 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
11/10/2021 |
LEVETIRACETAM ANDA #202095 |
SUPPL-7 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
11/10/2021 |
LEVETIRACETAM ANDA #202095 |
SUPPL-8 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
11/10/2021 |
CLOZAPINE ANDA #202873 |
SUPPL-11 |
CLOZAPINE |
ACCORD HLTHCARE |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #203039 |
SUPPL-12 |
CLOZAPINE |
TEVA PHARMS USA |
REMS |
Approval |
11/10/2021 |
VERSACLOZ NDA #203479 |
SUPPL-17 |
CLOZAPINE |
TASMAN PHARMA |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #203807 |
SUPPL-14 |
CLOZAPINE |
DR REDDYS LABS SA |
REMS |
Approval |
11/10/2021 |
CLOZAPINE ANDA #206433 |
SUPPL-13 |
CLOZAPINE |
AUROBINDO PHARMA |
REMS |
Approval |
11/10/2021 |
FINGOLIMOD HYDROCHLORIDE ANDA #207939 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
HEC PHARM CO LTD |
|
Approval |
11/10/2021 |
ENTECAVIR ANDA #208195 |
ORIG-1 |
ENTECAVIR |
YUNG SHIN PHARM |
|
Approval |
11/10/2021 |
CALCITONIN-SALMON ANDA #209358 |
ORIG-1 |
CALCITONIN SALMON |
PAR STERILE PRODUCTS |
|
Approval |
11/10/2021 |
LEVOCARNITINE ANDA #212533 |
ORIG-1 |
LEVOCARNITINE |
SAPTALIS PHARMS |
|
Approval |
11/10/2021 |
ELUXADOLINE ANDA #213522 |
ORIG-1 |
ELUXADOLINE |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
11/10/2021 |
GAVRETO NDA #213721 |
SUPPL-4 |
PRALSETINIB |
BLUEPRINT MEDICINES |
Labeling |
Approval |
11/11/2021 |
CIPRO NDA #019537 |
SUPPL-92 |
CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
11/12/2021 |
LUPRON DEPOT-PED KIT NDA #020263 |
SUPPL-48 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
11/12/2021 |
DIAZEPAM ANDA #070311 |
SUPPL-22 |
DIAZEPAM |
HIKMA |
Labeling |
Approval |
11/12/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #201048 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
11/12/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #201048 |
SUPPL-2 |
VANCOMYCIN HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
11/12/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #201048 |
SUPPL-3 |
VANCOMYCIN HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
11/12/2021 |
DOXEPIN HYDROCHLORIDE ANDA #202337 |
SUPPL-4 |
DOXEPIN HYDROCHLORIDE |
RK PHARMA |
Labeling |
Approval |
11/12/2021 |
LANSOPRAZOLE ANDA #202396 |
SUPPL-2 |
LANSOPRAZOLE |
MYLAN |
Labeling |
Approval |
11/12/2021 |
LANSOPRAZOLE ANDA #203083 |
SUPPL-1 |
LANSOPRAZOLE |
HETERO LABS LTD III |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-4 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-6 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-7 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-9 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-11 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
QUETIAPINE FUMARATE ANDA #204203 |
SUPPL-13 |
QUETIAPINE FUMARATE |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
PALONOSETRON HYDROCHLORIDE ANDA #206916 |
ORIG-1 |
PALONOSETRON HYDROCHLORIDE |
BAXTER HLTHCARE CORP |
|
Approval |
11/12/2021 |
NAFTIFINE HYDROCHLORIDE ANDA #208201 |
SUPPL-3 |
NAFTIFINE HYDROCHLORIDE |
TARO |
Labeling |
Approval |
11/12/2021 |
CLOBAZAM ANDA #208819 |
SUPPL-5 |
CLOBAZAM |
BIONPHARMA |
Labeling |
Approval |
11/12/2021 |
HALOPERIDOL DECANOATE ANDA #209101 |
SUPPL-5 |
HALOPERIDOL DECANOATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
11/12/2021 |
HALOPERIDOL DECANOATE ANDA #209101 |
SUPPL-6 |
HALOPERIDOL DECANOATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
11/12/2021 |
HALOPERIDOL DECANOATE ANDA #209101 |
SUPPL-7 |
HALOPERIDOL DECANOATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
11/12/2021 |
HALOPERIDOL DECANOATE ANDA #209101 |
SUPPL-8 |
HALOPERIDOL DECANOATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
11/12/2021 |
HALOPERIDOL DECANOATE ANDA #209101 |
SUPPL-11 |
HALOPERIDOL DECANOATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
11/12/2021 |
NEOSTIGMINE METHYLSULFATE ANDA #209182 |
SUPPL-3 |
NEOSTIGMINE METHYLSULFATE |
AM REGENT |
Labeling |
Approval |
11/12/2021 |
MEFENAMIC ACID ANDA #209209 |
SUPPL-1 |
MEFENAMIC ACID |
CHARTWELL RX |
Labeling |
Approval |
11/12/2021 |
ABIRATERONE ACETATE ANDA #209227 |
SUPPL-3 |
ABIRATERONE ACETATE |
GLENMARK PHARMS |
Labeling |
Approval |
11/12/2021 |
GABAPENTIN ANDA #209306 |
SUPPL-2 |
GABAPENTIN |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
GABAPENTIN ANDA #209306 |
SUPPL-3 |
GABAPENTIN |
LUPIN LTD |
Labeling |
Approval |
11/12/2021 |
ARSENIC TRIOXIDE ANDA #209315 |
SUPPL-5 |
ARSENIC TRIOXIDE |
INGENUS PHARMS LLC |
Labeling |
Approval |
11/12/2021 |
FETROJA NDA #209445 |
SUPPL-4 |
CEFIDEROCOL SULFATE TOSYLATE |
SHIONOGI INC |
Labeling |
Approval |
11/12/2021 |
FULVESTRANT NDA #210063 |
SUPPL-3 |
FULVESTRANT |
TEVA PHARMS USA INC |
Labeling |
Approval |
11/12/2021 |
CLOBAZAM ANDA #211711 |
SUPPL-3 |
CLOBAZAM |
MICRO LABS |
Labeling |
Approval |
11/12/2021 |
FINGOLIMOD HYDROCHLORIDE ANDA #212152 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
11/12/2021 |
NITAZOXANIDE ANDA #213820 |
SUPPL-1 |
NITAZOXANIDE |
RISING |
Manufacturing (CMC) |
Approval |
11/12/2021 |
DHIVY NDA #214869 |
ORIG-1 |
CARBIDOPA; LEVODOPA |
AVION PHARMS |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/12/2021 |
BENDAMUSTINE HYDROCHLORIDE NDA #215668 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
DR REDDYS LABS LTD |
Type 5 - New Formulation or New Manufacturer |
Tentative Approval |
11/12/2021 |
BESREMI BLA #761166 |
ORIG-1 |
ROPEGINTERFERON ALFA-2B-NJFT |
PHARMAESSENTIA CORP |
|
Approval |
11/14/2021 |
LANSOPRAZOLE ANDA #200816 |
SUPPL-1 |
LANSOPRAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
11/14/2021 |
LANSOPRAZOLE ANDA #200816 |
SUPPL-2 |
LANSOPRAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
11/15/2021 |
MICRONOR NDA #016954 |
SUPPL-100 |
NORETHINDRONE |
JANSSEN PHARMS |
Labeling |
Approval |
11/15/2021 |
MICRONOR NDA #016954 |
SUPPL-108 |
NORETHINDRONE |
JANSSEN PHARMS |
Labeling |
Approval |
11/15/2021 |
CLIMARA PRO NDA #021258 |
SUPPL-12 |
ESTRADIOL; LEVONORGESTREL |
BAYER HLTHCARE |
Labeling |
Approval |
11/15/2021 |
AZITHROMYCIN ANDA #065150 |
SUPPL-19 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
11/15/2021 |
AZITHROMYCIN ANDA #065360 |
SUPPL-9 |
AZITHROMYCIN |
AUROBINDO PHARMA USA |
Labeling |
Approval |
11/15/2021 |
RYDAPT NDA #207997 |
SUPPL-8 |
MIDOSTAURIN |
NOVARTIS |
Labeling |
Approval |
11/15/2021 |
CLOBAZAM ANDA #208785 |
SUPPL-1 |
CLOBAZAM |
HIKMA |
Labeling |
Approval |
11/15/2021 |
ACYCLOVIR ANDA #212202 |
ORIG-1 |
ACYCLOVIR |
PRINSTON INC |
|
Approval |
11/15/2021 |
OMEGA-3-ACID ETHYL ESTERS ANDA #215458 |
ORIG-1 |
OMEGA-3-ACID ETHYL ESTERS |
MANKIND PHARMA |
|
Approval |
11/15/2021 |
MVASI BLA #761028 |
SUPPL-8 |
BEVACIZUMAB-AWWB |
AMGEN INC |
|
Approval |
11/15/2021 |
RUXIENCE BLA #761103 |
SUPPL-5 |
RITUXIMAB-PVVR |
PFIZER INC |
|
Approval |
11/16/2021 |
MOTRIN IB NDA #019012 |
SUPPL-59 |
IBUPROFEN |
J AND J CONSUMER INC |
Labeling |
Approval |
11/16/2021 |
MOTRIN MIGRAINE PAIN NDA #019012 |
SUPPL-59 |
IBUPROFEN |
J AND J CONSUMER INC |
Labeling |
Approval |
11/16/2021 |
NUPRIN NDA #019012 |
SUPPL-59 |
IBUPROFEN |
J AND J CONSUMER INC |
Labeling |
Approval |
11/16/2021 |
FENOFIBRIC ACID ANDA #200913 |
SUPPL-7 |
CHOLINE FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
11/16/2021 |
FENOFIBRATE (MICRONIZED) ANDA #202252 |
SUPPL-9 |
FENOFIBRATE |
APOTEX |
Labeling |
Approval |
11/16/2021 |
PALIPERIDONE ANDA #202645 |
SUPPL-13 |
PALIPERIDONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
11/16/2021 |
OLOPATADINE HYDROCHLORIDE ANDA #202853 |
SUPPL-11 |
OLOPATADINE HYDROCHLORIDE |
PADAGIS ISRAEL |
Labeling |
Approval |
11/16/2021 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #202916 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203059 |
SUPPL-22 |
LEVETIRACETAM |
SUN PHARM |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-1 |
LEVETIRACETAM |
PRINSTON INC |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-3 |
LEVETIRACETAM |
PRINSTON INC |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-5 |
LEVETIRACETAM |
PRINSTON INC |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-6 |
LEVETIRACETAM |
PRINSTON INC |
Labeling |
Approval |
11/16/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-8 |
LEVETIRACETAM |
PRINSTON INC |
Labeling |
Approval |
11/16/2021 |
VAZALORE NDA #203697 |
SUPPL-8 |
ASPIRIN |
PLX PHARMA |
Labeling |
Approval |
11/16/2021 |
METOPROLOL TARTRATE ANDA #204205 |
SUPPL-4 |
METOPROLOL TARTRATE |
GLAND PHARMA LTD |
Labeling |
Approval |
11/16/2021 |
DUTASTERIDE ANDA #204262 |
SUPPL-9 |
DUTASTERIDE |
STRIDES PHARMA |
Labeling |
Approval |
11/16/2021 |
BUDESONIDE ANDA #205710 |
SUPPL-17 |
BUDESONIDE |
CIPLA |
Labeling |
Approval |
11/16/2021 |
IMVEXXY NDA #208564 |
SUPPL-2 |
ESTRADIOL |
MAYNE PHARMA |
Labeling |
Approval |
11/16/2021 |
ASPIRIN AND DIPYRIDAMOLE ANDA #210318 |
SUPPL-3 |
ASPIRIN; DIPYRIDAMOLE |
GLENMARK PHARMS SA |
Labeling |
Approval |
11/16/2021 |
MUPIROCIN ANDA #213053 |
ORIG-1 |
MUPIROCIN CALCIUM |
ALEMBIC |
|
Approval |
11/16/2021 |
TIAGABINE HYDROCHLORIDE ANDA #214816 |
ORIG-1 |
TIAGABINE HYDROCHLORIDE |
MSN |
|
Approval |
11/16/2021 |
SILDENAFIL CITRATE ANDA #215522 |
ORIG-1 |
SILDENAFIL CITRATE |
TARO |
|
Approval |
11/16/2021 |
PREDNISONE ANDA #215671 |
ORIG-1 |
PREDNISONE |
AUROBINDO PHARMA LTD |
|
Approval |
11/17/2021 |
TIMOPTIC NDA #018086 |
SUPPL-80 |
TIMOLOL MALEATE |
BAUSCH AND LOMB INC |
Labeling |
Approval |
11/17/2021 |
AROMASIN NDA #020753 |
SUPPL-22 |
EXEMESTANE |
PFIZER |
Labeling |
Approval |
11/17/2021 |
FLUORESCITE NDA #021980 |
SUPPL-7 |
FLUORESCEIN SODIUM |
ALCON LABS INC |
Labeling |
Approval |
11/17/2021 |
AZASITE NDA #050810 |
SUPPL-19 |
AZITHROMYCIN |
THEA PHARMA |
Labeling |
Approval |
11/17/2021 |
CHLORHEXIDINE GLUCONATE ANDA #075561 |
SUPPL-14 |
CHLORHEXIDINE GLUCONATE |
BAJAJ |
Manufacturing (CMC) |
Approval |
11/17/2021 |
KEYTRUDA BLA #125514 |
SUPPL-113 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
11/17/2021 |
LEVETIRACETAM ANDA #203468 |
SUPPL-7 |
LEVETIRACETAM |
PRINSTON INC |
Manufacturing (CMC) |
Approval |
11/17/2021 |
OXALIPLATIN ANDA #204368 |
SUPPL-3 |
OXALIPLATIN |
QILU PHARM HAINAN |
Labeling |
Approval |
11/17/2021 |
OXALIPLATIN ANDA #204368 |
SUPPL-5 |
OXALIPLATIN |
QILU PHARM HAINAN |
Labeling |
Approval |
11/17/2021 |
SIVEXTRO NDA #205435 |
SUPPL-14 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Labeling |
Approval |
11/17/2021 |
SIVEXTRO NDA #205436 |
SUPPL-9 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Labeling |
Approval |
11/17/2021 |
DIFLUPREDNATE ANDA #211526 |
ORIG-1 |
DIFLUPREDNATE |
AMNEAL |
|
Approval |
11/17/2021 |
SILDENAFIL CITRATE ANDA #212312 |
ORIG-1 |
SILDENAFIL CITRATE |
TRIS PHARMA INC |
|
Approval |
11/17/2021 |
GALLIUM GA 68 GOZETOTIDE NDA #212642 |
SUPPL-1 |
GALLIUM GA-68 GOZETOTIDE |
UNIV CA LOS ANGELES |
Labeling |
Approval |
11/17/2021 |
GALLIUM GA 68 GOZETOTIDE NDA #212643 |
SUPPL-1 |
GALLIUM GA-68 GOZETOTIDE |
UNIV OF CA SAN FRAN |
Labeling |
Approval |
11/17/2021 |
SOAANZ NDA #213218 |
SUPPL-1 |
TORSEMIDE |
SARFE PHARMS |
Manufacturing (CMC) |
Approval |
11/17/2021 |
NALOXONE HYDROCHLORIDE ANDA #213279 |
SUPPL-2 |
NALOXONE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
11/17/2021 |
ELUXADOLINE ANDA #213447 |
ORIG-1 |
ELUXADOLINE |
SUN PHARM INDS LTD |
|
Tentative Approval |
11/17/2021 |
NELARABINE ANDA #215037 |
ORIG-1 |
NELARABINE |
ZYDUS PHARMS |
|
Approval |
11/17/2021 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ANDA #215047 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
NOVAST LABS |
|
Approval |
11/17/2021 |
KETOCONAZOLE ANDA #215185 |
ORIG-1 |
KETOCONAZOLE |
TASMAN PHARMA |
|
Approval |
11/18/2021 |
REMERON NDA #020415 |
SUPPL-38 |
MIRTAZAPINE |
ORGANON |
Labeling |
Approval |
11/18/2021 |
REMERON SOLTAB NDA #021208 |
SUPPL-28 |
MIRTAZAPINE |
ORGANON USA ORGANON |
Labeling |
Approval |
11/18/2021 |
AMPYRA NDA #022250 |
SUPPL-19 |
DALFAMPRIDINE |
ACORDA |
Labeling |
Approval |
11/18/2021 |
OXALIPLATIN ANDA #078811 |
SUPPL-19 |
OXALIPLATIN |
FRESENIUS KABI USA |
Labeling |
Approval |
11/18/2021 |
OXALIPLATIN ANDA #078813 |
SUPPL-10 |
OXALIPLATIN |
HOSPIRA WORLDWIDE |
Labeling |
Approval |
11/18/2021 |
OXALIPLATIN ANDA #078817 |
SUPPL-25 |
OXALIPLATIN |
SANDOZ |
Labeling |
Approval |
11/18/2021 |
RASAGILINE MESYLATE ANDA #201942 |
ORIG-1 |
RASAGILINE MESYLATE |
CARNEGIE |
|
Approval |
11/18/2021 |
MESALAMINE ANDA #203286 |
SUPPL-3 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
11/18/2021 |
MESALAMINE ANDA #203286 |
SUPPL-4 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
11/18/2021 |
MESALAMINE ANDA #203286 |
SUPPL-7 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
11/18/2021 |
OLANZAPINE ANDA #204319 |
SUPPL-1 |
OLANZAPINE |
QILU |
Labeling |
Approval |
11/18/2021 |
OLANZAPINE ANDA #204319 |
SUPPL-3 |
OLANZAPINE |
QILU |
Labeling |
Approval |
11/18/2021 |
OLANZAPINE ANDA #204319 |
SUPPL-7 |
OLANZAPINE |
QILU |
Labeling |
Approval |
11/18/2021 |
OLANZAPINE ANDA #204319 |
SUPPL-8 |
OLANZAPINE |
QILU |
Labeling |
Approval |
11/18/2021 |
DEXAMETHASONE SODIUM PHOSPHATE ANDA #209192 |
SUPPL-3 |
DEXAMETHASONE SODIUM PHOSPHATE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/18/2021 |
VANCOMYCIN HYDROCHLORIDE ANDA #215821 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
HAINAN POLY |
|
Approval |
11/19/2021 |
CALAN NDA #018817 |
SUPPL-35 |
VERAPAMIL HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
11/19/2021 |
ADVIL COLD AND SINUS NDA #019771 |
SUPPL-45 |
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/19/2021 |
SUBUTEX NDA #020732 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
11/19/2021 |
SUBOXONE NDA #020733 |
SUPPL-29 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
11/19/2021 |
ADVIL COLD AND SINUS NDA #021374 |
SUPPL-14 |
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/19/2021 |
CALDOLOR NDA #022348 |
SUPPL-21 |
IBUPROFEN |
CUMBERLAND PHARMS |
Efficacy |
Approval |
11/19/2021 |
SUBOXONE NDA #022410 |
SUPPL-44 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
INDIVIOR |
REMS |
Approval |
11/19/2021 |
ADVIL CONGESTION RELIEF NDA #022565 |
SUPPL-9 |
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/19/2021 |
KANUMA BLA #125561 |
SUPPL-13 |
SEBELIPASE ALFA |
ALEXION PHARM |
|
Approval |
11/19/2021 |
OLANZAPINE ANDA #202862 |
SUPPL-10 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/19/2021 |
OLANZAPINE ANDA #202862 |
SUPPL-11 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/19/2021 |
OLANZAPINE ANDA #202862 |
SUPPL-18 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/19/2021 |
OLANZAPINE ANDA #202862 |
SUPPL-25 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/19/2021 |
OLANZAPINE ANDA #202862 |
SUPPL-26 |
OLANZAPINE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/19/2021 |
INJECTAFER NDA #203565 |
SUPPL-16 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Efficacy |
Approval |
11/19/2021 |
NEBIVOLOL HYDROCHLORIDE ANDA #203828 |
SUPPL-3 |
NEBIVOLOL HYDROCHLORIDE |
INDCHEMIE HEALTH |
Labeling |
Approval |
11/19/2021 |
ISOPROTERENOL HYDROCHLORIDE ANDA #212189 |
ORIG-1 |
ISOPROTERENOL HYDROCHLORIDE |
AVET LIFESCIENCES |
|
Approval |
11/19/2021 |
DEFERASIROX ANDA #214180 |
ORIG-1 |
DEFERASIROX |
TEVA PHARMS USA |
|
Approval |
11/19/2021 |
DECITABINE ANDA #214486 |
ORIG-1 |
DECITABINE |
ZYDUS PHARMS |
|
Approval |
11/19/2021 |
VOXZOGO NDA #214938 |
ORIG-1 |
VOSORITIDE |
BIOMARIN PHARM |
Type 1 - New Molecular Entity |
Approval |
11/22/2021 |
MERCAPTOPURINE ANDA #040528 |
SUPPL-12 |
MERCAPTOPURINE |
HIKMA |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050670 |
SUPPL-36 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050693 |
SUPPL-34 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050710 |
SUPPL-51 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050711 |
SUPPL-50 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050730 |
SUPPL-43 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050733 |
SUPPL-50 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZITHROMAX NDA #050784 |
SUPPL-37 |
AZITHROMYCIN |
PFIZER |
Labeling |
Approval |
11/22/2021 |
ZMAX NDA #050797 |
SUPPL-26 |
AZITHROMYCIN |
PF PRISM CV |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065150 |
SUPPL-20 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065209 |
SUPPL-32 |
AZITHROMYCIN |
SANDOZ |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065218 |
SUPPL-24 |
AZITHROMYCIN |
PLIVA |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065302 |
SUPPL-11 |
AZITHROMYCIN |
CHARTWELL RX |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065360 |
SUPPL-10 |
AZITHROMYCIN |
AUROBINDO PHARMA USA |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #065400 |
SUPPL-19 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
11/22/2021 |
CIMETIDINE HYDROCHLORIDE ANDA #074553 |
SUPPL-8 |
CIMETIDINE HYDROCHLORIDE |
PHARM ASSOC |
Manufacturing (CMC) |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #207566 |
SUPPL-2 |
AZITHROMYCIN |
CSPC OUYI |
Labeling |
Approval |
11/22/2021 |
DOXYCYCLINE HYCLATE ANDA #208263 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
NESHER PHARMS |
|
Approval |
11/22/2021 |
ABIRATERONE ACETATE ANDA #208453 |
SUPPL-1 |
ABIRATERONE ACETATE |
APOTEX |
Labeling |
Approval |
11/22/2021 |
ABIRATERONE ACETATE ANDA #208453 |
SUPPL-9 |
ABIRATERONE ACETATE |
APOTEX |
Labeling |
Approval |
11/22/2021 |
ABIRATERONE ACETATE ANDA #208453 |
SUPPL-11 |
ABIRATERONE ACETATE |
APOTEX |
Labeling |
Approval |
11/22/2021 |
ABIRATERONE ACETATE ANDA #208453 |
SUPPL-12 |
ABIRATERONE ACETATE |
APOTEX |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #209043 |
SUPPL-8 |
AZITHROMYCIN |
SUNSHINE |
Labeling |
Approval |
11/22/2021 |
SILODOSIN ANDA #209745 |
SUPPL-3 |
SILODOSIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #209999 |
SUPPL-2 |
AZITHROMYCIN |
BIONPHARMA |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #211068 |
SUPPL-2 |
AZITHROMYCIN |
YUNG SHIN PHARM |
Labeling |
Approval |
11/22/2021 |
AZITHROMYCIN ANDA #211793 |
SUPPL-5 |
AZITHROMYCIN |
ALEMBIC |
Labeling |
Approval |
11/22/2021 |
FYARRO NDA #213312 |
ORIG-1 |
SIROLIMUS |
AADI |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/22/2021 |
CANGRELOR ANDA #213703 |
ORIG-1 |
CANGRELOR |
MSN PHARMACEUTICALS INC |
|
Tentative Approval |
11/22/2021 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #214347 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
ACCORD HLTHCARE |
|
Approval |
11/22/2021 |
NIACIN ANDA #214428 |
ORIG-1 |
NIACIN |
BEIJING |
|
Approval |
11/22/2021 |
FORMOTEROL FUMARATE ANDA #215078 |
ORIG-1 |
FORMOTEROL FUMARATE |
ALEMBIC |
|
Approval |
11/22/2021 |
DIGOXIN ANDA #215307 |
ORIG-1 |
DIGOXIN |
NOVITIUM PHARMA |
|
Approval |
11/22/2021 |
LYVISPAH NDA #215422 |
ORIG-1 |
BACLOFEN |
AMNEAL |
Type 3 - New Dosage Form |
Approval |
11/22/2021 |
ULTOMIRIS BLA #761108 |
SUPPL-24 |
RAVULIZUMAB-CWVZ |
ALEXION PHARM |
|
Approval |
11/23/2021 |
ADVIL ALLERGY SINUS NDA #021441 |
SUPPL-16 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/23/2021 |
ADVIL ALLERGY AND CONGESTION RELIEF NDA #022113 |
SUPPL-11 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/23/2021 |
ADVIL MULTI-SYMPTOM COLD & FLU NDA #022113 |
SUPPL-11 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
11/23/2021 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #078992 |
ORIG-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
INTELLIPHARMACEUTICS |
|
Approval |
11/23/2021 |
DASATINIB ANDA #203180 |
ORIG-1 |
DASATINIB |
APOTEX |
|
Approval |
11/23/2021 |
EVEROLIMUS ANDA #207486 |
ORIG-2 |
EVEROLIMUS |
HIKMA |
|
Approval |
11/23/2021 |
TPOXX NDA #208627 |
SUPPL-6 |
TECOVIRIMAT |
SIGA TECHNOLOGIES |
Efficacy |
Approval |
11/23/2021 |
ISOSORBIDE DINITRATE ANDA #211290 |
ORIG-1 |
ISOSORBIDE DINITRATE |
PAR PHARM INC |
|
Approval |
11/23/2021 |
INREBIC NDA #212327 |
SUPPL-4 |
FEDRATINIB HYDROCHLORIDE |
BRISTOL-MYERS |
Labeling |
Approval |
11/23/2021 |
TEMOZOLOMIDE ANDA #213328 |
ORIG-1 |
TEMOZOLOMIDE |
NIVAGEN PHARMS INC |
|
Approval |
11/23/2021 |
BETAINE ANDA #214864 |
ORIG-1 |
BETAINE |
NOVITIUM PHARMA |
|
Approval |
11/23/2021 |
LIVTENCITY NDA #215596 |
ORIG-1 |
MARIBAVIR |
TAKEDA PHARMS USA |
Type 1 - New Molecular Entity |
Approval |
11/24/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE ANDA #077528 |
SUPPL-19 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE ANDA #077528 |
SUPPL-20 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
11/24/2021 |
BUPRENORPHINE HYDROCHLORIDE ANDA #078633 |
SUPPL-24 |
BUPRENORPHINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE ANDA #202074 |
SUPPL-18 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-2 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-3 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-5 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-6 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-7 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-8 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202285 |
SUPPL-10 |
OLANZAPINE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202287 |
SUPPL-2 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202287 |
SUPPL-3 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202287 |
SUPPL-4 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/24/2021 |
OLANZAPINE ANDA #202287 |
SUPPL-5 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #202366 |
SUPPL-3 |
LANSOPRAZOLE |
ZYDUS HLTHCARE |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #202366 |
SUPPL-4 |
LANSOPRAZOLE |
ZYDUS HLTHCARE |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #202366 |
SUPPL-5 |
LANSOPRAZOLE |
ZYDUS HLTHCARE |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #202366 |
SUPPL-7 |
LANSOPRAZOLE |
ZYDUS HLTHCARE |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #202366 |
SUPPL-8 |
LANSOPRAZOLE |
ZYDUS HLTHCARE |
Labeling |
Approval |
11/24/2021 |
LANSOPRAZOLE ANDA #203187 |
SUPPL-3 |
LANSOPRAZOLE |
MYLAN |
Labeling |
Approval |
11/24/2021 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #205022 |
SUPPL-11 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
11/26/2021 |
INTRON A BLA #103132 |
SUPPL-5202 |
INTERFERON ALFA-2B |
SCHERING |
|
Approval |
11/26/2021 |
EVEROLIMUS ANDA #214138 |
ORIG-1 |
EVEROLIMUS |
ALKEM LABS LTD |
|
Approval |
11/26/2021 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #214403 |
ORIG-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
LANNETT CO INC |
|
Approval |
11/26/2021 |
DAPTOMYCIN ANDA #215215 |
ORIG-1 |
DAPTOMYCIN |
HANGZHOU ZHONGMEI |
|
Approval |
11/26/2021 |
ATROPINE SULFATE ANDA #215624 |
ORIG-1 |
ATROPINE SULFATE |
APOTEX |
|
Approval |
11/29/2021 |
AZTREONAM ANDA #065439 |
SUPPL-9 |
AZTREONAM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/29/2021 |
AZTREONAM ANDA #065439 |
SUPPL-14 |
AZTREONAM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/29/2021 |
RIBAVIRIN ANDA #076277 |
SUPPL-13 |
RIBAVIRIN |
TEVA |
Labeling |
Approval |
11/29/2021 |
URSODIOL ANDA #090801 |
SUPPL-5 |
URSODIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/29/2021 |
FENOFIBRIC ACID ANDA #200264 |
SUPPL-4 |
CHOLINE FENOFIBRATE |
IMPAX LABS INC |
Labeling |
Approval |
11/29/2021 |
FENOFIBRIC ACID ANDA #200750 |
SUPPL-16 |
CHOLINE FENOFIBRATE |
CHARTWELL RX |
Labeling |
Approval |
11/29/2021 |
OLANZAPINE ANDA #202937 |
SUPPL-1 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/29/2021 |
OLANZAPINE ANDA #202937 |
SUPPL-2 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/29/2021 |
OLANZAPINE ANDA #202937 |
SUPPL-3 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/29/2021 |
OLANZAPINE ANDA #202937 |
SUPPL-4 |
OLANZAPINE |
ORBION PHARMS |
Labeling |
Approval |
11/29/2021 |
LUMIFY NDA #208144 |
SUPPL-13 |
BRIMONIDINE TARTRATE |
BAUSCH AND LOMB INC |
Labeling |
Approval |
11/29/2021 |
MIGLUSTAT ANDA #208342 |
SUPPL-3 |
MIGLUSTAT |
ANI PHARMS |
Labeling |
Approval |
11/29/2021 |
CHLORPROMAZINE HYDROCHLORIDE ANDA #212630 |
ORIG-1 |
CHLORPROMAZINE HYDROCHLORIDE |
ZAMEER PHARMS |
|
Approval |
11/29/2021 |
MYCOPHENOLIC SODIUM ANDA #214630 |
ORIG-1 |
MYCOPHENOLIC SODIUM |
BIOCON PHARMA |
|
Approval |
11/29/2021 |
CYTALUX NDA #214907 |
ORIG-1 |
PAFOLACIANINE SODIUM |
ON TARGET LABS |
Type 1 - New Molecular Entity |
Approval |
11/30/2021 |
DEPAKOTE NDA #018723 |
SUPPL-65 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/30/2021 |
DEPAKOTE NDA #019680 |
SUPPL-52 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/30/2021 |
ESTROGEL NDA #021166 |
SUPPL-17 |
ESTRADIOL |
ASCEND THERAPS US |
Labeling |
Approval |
11/30/2021 |
DEPAKOTE ER NDA #021168 |
SUPPL-43 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/30/2021 |
FERRIPROX NDA #021825 |
SUPPL-10 |
DEFERIPRONE |
CHIESI |
Labeling |
Approval |
11/30/2021 |
STAVZOR NDA #022152 |
SUPPL-9 |
VALPROIC ACID |
BIONPHARMA |
Labeling |
Approval |
11/30/2021 |
MESALAMINE ANDA #202065 |
SUPPL-1 |
MESALAMINE |
SANDOZ |
Labeling |
Approval |
11/30/2021 |
KYPROLIS NDA #202714 |
SUPPL-33 |
CARFILZOMIB |
ONYX PHARMS AMGEN |
Efficacy |
Approval |
11/30/2021 |
POLYETHYLENE GLYCOL 3350 ANDA #202850 |
SUPPL-2 |
POLYETHYLENE GLYCOL 3350 |
ANI PHARMS |
Labeling |
Approval |
11/30/2021 |
FERRIPROX NDA #208030 |
SUPPL-7 |
DEFERIPRONE |
CHIESI |
Labeling |
Approval |
11/30/2021 |
LUBIPROSTONE ANDA #209450 |
ORIG-1 |
LUBIPROSTONE |
AMNEAL |
|
Approval |
11/30/2021 |
ATORVASTATIN CALCIUM ANDA #209912 |
SUPPL-10 |
ATORVASTATIN CALCIUM |
GRAVITI PHARMS |
Labeling |
Approval |
11/30/2021 |
ATORVASTATIN CALCIUM ANDA #209912 |
SUPPL-17 |
ATORVASTATIN CALCIUM |
GRAVITI PHARMS |
Labeling |
Approval |
11/30/2021 |
ATORVASTATIN CALCIUM ANDA #209912 |
SUPPL-18 |
ATORVASTATIN CALCIUM |
GRAVITI PHARMS |
Labeling |
Approval |
11/30/2021 |
BACLOFEN ANDA #211555 |
SUPPL-6 |
BACLOFEN |
EYWA PHARMA |
Manufacturing (CMC) |
Approval |
11/30/2021 |
FERRIPROX NDA #212269 |
SUPPL-3 |
DEFERIPRONE |
CHIESI |
Labeling |
Approval |
11/30/2021 |
SUNITINIB MALATE ANDA #213803 |
ORIG-1 |
SUNITINIB MALATE |
TEVA PHARMS USA |
|
Approval |
11/30/2021 |
DARZALEX FASPRO BLA #761145 |
SUPPL-9 |
DARATUMUMAB;HYALURONIDASE-FIHJ |
JANSSEN BIOTECH |
|
Approval |