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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 2020

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on June 15, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/03/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-29 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
08/03/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-30 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
08/03/2020 VIGABATRIN
ANDA #209824		 SUPPL-1 VIGABATRIN TEVA PHARMS USA Labeling Approval
08/03/2020 VIGABATRIN
ANDA #209824		 SUPPL-6 VIGABATRIN TEVA PHARMS USA Labeling Approval
08/03/2020 MIFEPRISTONE
ANDA #211436		 ORIG-1 MIFEPRISTONE TEVA PHARMS USA INC Approval
08/03/2020 EMPAGLIFLOZIN
ANDA #212331		 ORIG-1 EMPAGLIFLOZIN LUPIN LTD Tentative Approval
08/03/2020 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #212435		 ORIG-1 METRONIDAZOLE GLAND PHARMA LTD Approval
08/03/2020 VASOPRESSIN
NDA #212593		 ORIG-1 VASOPRESSIN AM REGENT Type 5 - New Formulation or New Manufacturer Approval
08/04/2020 PIPERACILLIN
ANDA #065157		 SUPPL-10 PIPERACILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
08/04/2020 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-19 MYCOPHENOLATE MOFETIL TEVA PHARMS Labeling Approval
08/04/2020 MYCOPHENOLATE MOFETIL
ANDA #090055		 SUPPL-16 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
08/04/2020 MYCOPHENOLATE MOFETIL
ANDA #090456		 SUPPL-18 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
08/04/2020 CONTRAVE
NDA #200063		 SUPPL-15 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Labeling Approval
08/04/2020 CLONIDINE HYDROCHLORIDE
ANDA #202984		 SUPPL-9 CLONIDINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
08/04/2020 CLONIDINE HYDROCHLORIDE
ANDA #202984		 SUPPL-12 CLONIDINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
08/04/2020 GEMCITABINE HYDROCHLORIDE
ANDA #206776		 SUPPL-4 GEMCITABINE HYDROCHLORIDE APOTEX Labeling Approval
08/04/2020 EPHEDRINE SULFATE
ANDA #209646		 ORIG-1 EPHEDRINE SULFATE FRESENIUS KABI USA Approval
08/04/2020 CLONIDINE HYDROCHLORIDE
ANDA #209686		 SUPPL-7 CLONIDINE HYDROCHLORIDE AJANTA PHARMA LTD Labeling Approval
08/04/2020 METHOCARBAMOL
ANDA #211504		 SUPPL-1 METHOCARBAMOL GLAND PHARMA LTD Labeling Approval
08/04/2020 TURALIO
NDA #211810		 SUPPL-5 PEXIDARTINIB HYDROCHLORIDE DAIICHI SANKYO INC REMS Approval
08/04/2020 PENICILLAMINE
ANDA #211867		 ORIG-1 PENICILLAMINE DR REDDYS Approval
08/04/2020 NINTEDANIB
ANDA #212732		 ORIG-1 NINTEDANIB ACCORD HLTHCARE INC Tentative Approval
08/04/2020 NICOTINE POLACRILEX
ANDA #213233		 ORIG-1 NICOTINE POLACRILEX DR REDDYS LABS SA Approval
08/04/2020 XTANDI
NDA #213674		 ORIG-1 ENZALUTAMIDE ASTELLAS Type 3 - New Dosage Form Approval
08/04/2020 VARDENAFIL HYDROCHLORIDE
ANDA #214031		 ORIG-1 VARDENAFIL HYDROCHLORIDE ALEMBIC Approval
08/05/2020 ZYVOX
NDA #021130		 SUPPL-39 LINEZOLID PFIZER Labeling Approval
08/05/2020 ZYVOX
NDA #021130		 SUPPL-40 LINEZOLID PFIZER Labeling Approval
08/05/2020 ZYVOX
NDA #021131		 SUPPL-34 LINEZOLID PFIZER Labeling Approval
08/05/2020 ZYVOX
NDA #021131		 SUPPL-35 LINEZOLID PFIZER Labeling Approval
08/05/2020 ZYVOX
NDA #021132		 SUPPL-38 LINEZOLID PFIZER Labeling Approval
08/05/2020 ZYVOX
NDA #021132		 SUPPL-39 LINEZOLID PFIZER Labeling Approval
08/05/2020 VICTOZA
NDA #022341		 SUPPL-35 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
08/05/2020 SUPREP BOWEL PREP KIT
NDA #022372		 SUPPL-13 MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE BRAINTREE LABS Efficacy Approval
08/05/2020 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #079182		 SUPPL-4 OMEPRAZOLE; SODIUM BICARBONATE STRIDES PHARMA Labeling Approval
08/05/2020 HERCEPTIN
BLA #103792		 SUPPL-5349 TRASTUZUMAB GENENTECH Approval
08/05/2020 SEVELAMER CARBONATE
ANDA #201069		 ORIG-1 SEVELAMER CARBONATE STRIDES PHARMA Approval
08/05/2020 TOLTERODINE TARTRATE
ANDA #205399		 ORIG-1 TOLTERODINE TARTRATE UNICHEM Approval
08/05/2020 MACITENTAN
ANDA #211161		 ORIG-1 MACITENTAN MYLAN PHARMS INC Tentative Approval
08/06/2020 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #040491		 SUPPL-10 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
08/06/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #040572		 SUPPL-4 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
08/06/2020 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040583		 SUPPL-8 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
08/06/2020 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #040612		 SUPPL-8 METHYLPREDNISOLONE SODIUM SUCCINATE FRESENIUS KABI USA Labeling Approval
08/06/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070182		 SUPPL-29 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/06/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070183		 SUPPL-28 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/06/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070543		 SUPPL-25 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/06/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070544		 SUPPL-26 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/06/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071060		 SUPPL-15 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/06/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071061		 SUPPL-15 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/06/2020 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #073357		 SUPPL-8 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/06/2020 HYDROCHLOROTHIAZIDE
ANDA #084912		 SUPPL-70 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/06/2020 HYDROCHLOROTHIAZIDE
ANDA #087565		 SUPPL-26 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/06/2020 ROPINIROLE HYDROCHLORIDE
ANDA #090135		 SUPPL-8 ROPINIROLE HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
08/06/2020 ROPINIROLE HYDROCHLORIDE
ANDA #090135		 SUPPL-9 ROPINIROLE HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
08/06/2020 ROPINIROLE HYDROCHLORIDE
ANDA #090135		 SUPPL-10 ROPINIROLE HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
08/06/2020 OLOPATADINE HYDROCHLORIDE
ANDA #090918		 SUPPL-5 OLOPATADINE HYDROCHLORIDE APOTEX Labeling Approval
08/06/2020 RISEDRONATE SODIUM
ANDA #200296		 SUPPL-4 RISEDRONATE SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/06/2020 IBUPROFEN
ANDA #203599		 SUPPL-6 IBUPROFEN SOFGEN PHARMS Manufacturing (CMC) Approval
08/06/2020 DICLOFENAC SODIUM
ANDA #204306		 SUPPL-1 DICLOFENAC SODIUM AUROLIFE PHARMA LLC Manufacturing (CMC) Approval
08/06/2020 TOPOTECAN HYDROCHLORIDE
ANDA #206074		 SUPPL-3 TOPOTECAN HYDROCHLORIDE DASH PHARMS Labeling Approval
08/06/2020 AZACITIDINE
ANDA #207518		 SUPPL-7 AZACITIDINE SHILPA MEDICARE Labeling Approval
08/06/2020 NARCAN
NDA #208411		 SUPPL-4 NALOXONE HYDROCHLORIDE EMERGENT Manufacturing (CMC) Approval
08/06/2020 YARGESA
ANDA #209821		 ORIG-1 MIGLUSTAT EDENBRIDGE PHARMS Approval
08/06/2020 DOVATO
NDA #211994		 SUPPL-6 DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
08/06/2020 DOVATO
NDA #211994		 SUPPL-7 DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
08/06/2020 SILDENAFIL CITRATE
ANDA #213041		 ORIG-1 SILDENAFIL CITRATE APTAPHARMA INC Approval
08/06/2020 SILDENAFIL CITRATE
ANDA #213041		 SUPPL-1 SILDENAFIL CITRATE APTAPHARMA INC Approval
08/06/2020 LAMPIT
NDA #213464		 ORIG-1 NIFURTIMOX BAYER HEALTHCARE Type 1 - New Molecular Entity Approval
08/07/2020 CYTOXAN
NDA #012141		 SUPPL-91 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/07/2020 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-34 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
08/07/2020 CLARITIN
NDA #021891		 SUPPL-34 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
08/07/2020 MITOSOL
NDA #022572		 SUPPL-8 MITOMYCIN MOBIUS THERAP Manufacturing (CMC) Approval
08/07/2020 METHYLPREDNISOLONE ACETATE
ANDA #040557		 SUPPL-27 METHYLPREDNISOLONE ACETATE HONG KONG Labeling Approval
08/07/2020 METHYLPREDNISOLONE ACETATE
ANDA #040557		 SUPPL-30 METHYLPREDNISOLONE ACETATE HONG KONG Labeling Approval
08/07/2020 NAFCILLIN SODIUM
ANDA #062732		 SUPPL-16 NAFCILLIN SODIUM SANDOZ Labeling Approval
08/07/2020 NAFCILLIN SODIUM
ANDA #062732		 SUPPL-19 NAFCILLIN SODIUM SANDOZ Labeling Approval
08/07/2020 GABAPENTIN
ANDA #077242		 SUPPL-19 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
08/07/2020 GABAPENTIN
ANDA #077242		 SUPPL-20 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
08/07/2020 GABAPENTIN
ANDA #077242		 SUPPL-21 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
08/07/2020 BUPROPION HYDROCHLORIDE
ANDA #077415		 SUPPL-36 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
08/07/2020 ROCURONIUM BROMIDE
ANDA #078519		 SUPPL-16 ROCURONIUM BROMIDE HOSPIRA Labeling Approval
08/07/2020 ROCURONIUM BROMIDE
ANDA #078651		 SUPPL-7 ROCURONIUM BROMIDE FRESENIUS KABI USA Labeling Approval
08/07/2020 ROCURONIUM BROMIDE
ANDA #078651		 SUPPL-8 ROCURONIUM BROMIDE FRESENIUS KABI USA Labeling Approval
08/07/2020 DILANTIN
ANDA #084349		 SUPPL-86 PHENYTOIN SODIUM VIATRIS Labeling Approval
08/07/2020 LETROZOLE
ANDA #200161		 SUPPL-1 LETROZOLE NATCO PHARMA LTD Labeling Approval
08/07/2020 LETROZOLE
ANDA #200161		 SUPPL-4 LETROZOLE NATCO PHARMA LTD Labeling Approval
08/07/2020 METHYLPREDNISOLONE ACETATE
ANDA #201835		 SUPPL-1 METHYLPREDNISOLONE ACETATE SAGENT PHARMS INC Labeling Approval
08/07/2020 ACITRETIN
ANDA #202552		 SUPPL-5 ACITRETIN IMPAX LABS INC Labeling Approval
08/07/2020 CEFTRIAXONE
ANDA #203702		 SUPPL-4 CEFTRIAXONE SODIUM QILU Labeling Approval
08/07/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #204058		 SUPPL-4 HYDROCHLOROTHIAZIDE; LISINOPRIL INVAGEN PHARMS Labeling Approval
08/07/2020 IMBRUVICA
NDA #205552		 SUPPL-31 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
08/07/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #206726		 SUPPL-1 METHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
08/07/2020 RUFINAMIDE
ANDA #207363		 SUPPL-1 RUFINAMIDE HIKMA Labeling Approval
08/07/2020 FULVESTRANT
ANDA #209246		 ORIG-1 FULVESTRANT DR REDDYS Approval
08/07/2020 ICOSAPENT ETHYL
ANDA #209499		 ORIG-1 ICOSAPENT ETHYL DR REDDYS Approval
08/07/2020 IMBRUVICA
NDA #210563		 SUPPL-7 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
08/07/2020 OLINVYK
NDA #210730		 ORIG-1 OLICERIDINE TREVENA Type 1 - New Molecular Entity Approval
08/07/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #212285		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE UNIQUE Approval
08/07/2020 ACETAMINOPHEN
ANDA #213255		 ORIG-1 ACETAMINOPHEN MYLAN Approval
08/07/2020 EVRYSDI
NDA #213535		 ORIG-1 RISDIPLAM GENENTECH INC Type 1 - New Molecular Entity Approval
08/09/2020 METHYLPREDNISOLONE ACETATE
ANDA #040620		 SUPPL-22 METHYLPREDNISOLONE ACETATE TEVA PHARMS USA Labeling Approval
08/09/2020 METHYLPREDNISOLONE ACETATE
ANDA #040620		 SUPPL-24 METHYLPREDNISOLONE ACETATE TEVA PHARMS USA Labeling Approval
08/09/2020 METHYLPREDNISOLONE ACETATE
ANDA #040620		 SUPPL-26 METHYLPREDNISOLONE ACETATE TEVA PHARMS USA Labeling Approval
08/09/2020 METHYLPREDNISOLONE ACETATE
ANDA #040620		 SUPPL-30 METHYLPREDNISOLONE ACETATE TEVA PHARMS USA Labeling Approval
08/10/2020 SEPTRA
NDA #017376		 SUPPL-63 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/10/2020 SEPTRA
NDA #017376		 SUPPL-64 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/10/2020 SEPTRA DS
NDA #017376		 SUPPL-63 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/10/2020 SEPTRA DS
NDA #017376		 SUPPL-64 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
08/10/2020 GLEEVEC
NDA #021588		 SUPPL-56 IMATINIB MESYLATE NOVARTIS Labeling Approval
08/10/2020 GLEEVEC
NDA #021588		 SUPPL-57 IMATINIB MESYLATE NOVARTIS Labeling Approval
08/10/2020 GABAPENTIN
ANDA #078150		 SUPPL-16 GABAPENTIN HIKMA Labeling Approval
08/10/2020 GABAPENTIN
ANDA #078150		 SUPPL-17 GABAPENTIN HIKMA Labeling Approval
08/10/2020 CIPROFLOXACIN AND DEXAMETHASONE
ANDA #205548		 ORIG-1 CIPROFLOXACIN; DEXAMETHASONE DR REDDYS Approval
08/10/2020 ENTECAVIR
ANDA #212106		 ORIG-1 ENTECAVIR VITRUVIAS Approval
08/10/2020 EPLERENONE
ANDA #212765		 ORIG-1 EPLERENONE SLATE RUN PHARMA Approval
08/10/2020 MIDODRINE HYDROCHLORIDE
ANDA #212774		 ORIG-1 MIDODRINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
08/11/2020 VANCOCIN HYDROCHLORIDE
NDA #050606		 SUPPL-36 VANCOMYCIN HYDROCHLORIDE ANI PHARMS Labeling Approval
08/11/2020 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #088912		 SUPPL-31 SODIUM CHLORIDE FRESENIUS KABI USA Labeling Approval
08/11/2020 DOCETAXEL
NDA #201525		 SUPPL-20 DOCETAXEL SANDOZ Labeling Approval
08/11/2020 PROTRIPTYLINE HYDROCHLORIDE
ANDA #202220		 SUPPL-3 PROTRIPTYLINE HYDROCHLORIDE EPIC PHARMA LLC Manufacturing (CMC) Approval
08/11/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #203300		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HIKMA Approval
08/11/2020 TRANEXAMIC ACID
ANDA #203521		 SUPPL-13 TRANEXAMIC ACID AVET LIFESCIENCES Labeling Approval
08/11/2020 SEVOFLURANE
ANDA #203793		 SUPPL-2 SEVOFLURANE SHANGHAI HENGRUI Labeling Approval
08/11/2020 DONEPEZIL HYDROCHLORIDE
ANDA #203907		 SUPPL-12 DONEPEZIL HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
08/11/2020 FESOTERODINE FUMARATE
ANDA #206701		 ORIG-1 FESOTERODINE FUMARATE MYLAN PHARMS INC Tentative Approval
08/11/2020 SEVELAMER CARBONATE
ANDA #207759		 ORIG-1 SEVELAMER CARBONATE ZYDUS PHARMS Approval
08/11/2020 DICLOFENAC SODIUM
ANDA #210986		 SUPPL-1 DICLOFENAC SODIUM ENCUBE Labeling Approval
08/11/2020 RUFINAMIDE
ANDA #211388		 SUPPL-1 RUFINAMIDE BIONPHARMA Labeling Approval
08/11/2020 MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #211965		 ORIG-1 MAGNESIUM SULFATE BAXTER HLTHCARE CORP Approval
08/11/2020 AMINOCAPROIC ACID
ANDA #212494		 ORIG-1 AMINOCAPROIC ACID TULEX PHARMS INC Approval
08/12/2020 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #016694		 SUPPL-127 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
08/12/2020 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-18 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
08/12/2020 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-15 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
08/12/2020 BIMATOPROST
ANDA #202719		 SUPPL-1 BIMATOPROST SANDOZ Labeling Approval
08/12/2020 CINACALCET HYDROCHLORIDE
ANDA #203422		 SUPPL-2 CINACALCET HYDROCHLORIDE MYLAN Labeling Approval
08/12/2020 CINACALCET HYDROCHLORIDE
ANDA #203422		 SUPPL-3 CINACALCET HYDROCHLORIDE MYLAN Labeling Approval
08/12/2020 DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
ANDA #205947		 SUPPL-4 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM LUPIN LTD Manufacturing (CMC) Approval
08/12/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211078		 SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Labeling Approval
08/12/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211078		 SUPPL-6 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Labeling Approval
08/12/2020 NOREPINEPHRINE BITARTRATE
ANDA #211359		 SUPPL-1 NOREPINEPHRINE BITARTRATE SANDOZ Labeling Approval
08/12/2020 VILTEPSO
NDA #212154		 ORIG-1 VILTOLARSEN NIPPON SHINYAKU Type 1 - New Molecular Entity Approval
08/12/2020 METHOCARBAMOL
ANDA #213967		 ORIG-1 METHOCARBAMOL AUROBINDO PHARMA LTD Approval
08/13/2020 NEOMYCIN SULFATE
ANDA #060304		 SUPPL-50 NEOMYCIN SULFATE TEVA Labeling Approval
08/13/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065363		 SUPPL-21 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/13/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065363		 SUPPL-27 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/13/2020 PIPERACILLIN AND TAZOBACTAM
ANDA #065363		 SUPPL-35 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
08/13/2020 NAPROXEN SODIUM
ANDA #074198		 SUPPL-37 NAPROXEN SODIUM TEVA Labeling Approval
08/13/2020 NAPROXEN SODIUM
ANDA #074198		 SUPPL-38 NAPROXEN SODIUM TEVA Labeling Approval
08/13/2020 NAPROXEN SODIUM
ANDA #074198		 SUPPL-40 NAPROXEN SODIUM TEVA Labeling Approval
08/13/2020 BACLOFEN
ANDA #077068		 SUPPL-14 BACLOFEN ENDO OPERATIONS Labeling Approval
08/13/2020 EXEMESTANE
ANDA #077431		 SUPPL-8 EXEMESTANE HIKMA Labeling Approval
08/13/2020 EXEMESTANE
ANDA #077431		 SUPPL-9 EXEMESTANE HIKMA Labeling Approval
08/13/2020 FLUTICASONE PROPIONATE
ANDA #077538		 SUPPL-31 FLUTICASONE PROPIONATE APOTEX INC Labeling Approval
08/13/2020 HEPARIN SODIUM
ANDA #088100		 SUPPL-50 HEPARIN SODIUM HOSPIRA Labeling Approval
08/13/2020 HEPARIN SODIUM PRESERVATIVE FREE
ANDA #089522		 SUPPL-56 HEPARIN SODIUM HOSPIRA Labeling Approval
08/13/2020 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #091532		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE SAMSON MEDCL Labeling Approval
08/13/2020 YERVOY
BLA #125377		 SUPPL-111 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
08/13/2020 TEMOZOLOMIDE
ANDA #201528		 SUPPL-5 TEMOZOLOMIDE ACCORD HLTHCARE Labeling Approval
08/13/2020 LEVETIRACETAM
ANDA #203059		 SUPPL-12 LEVETIRACETAM SUN PHARM Labeling Approval
08/13/2020 LEVETIRACETAM
ANDA #203059		 SUPPL-13 LEVETIRACETAM SUN PHARM Labeling Approval
08/13/2020 LEVETIRACETAM
ANDA #203059		 SUPPL-20 LEVETIRACETAM SUN PHARM Labeling Approval
08/13/2020 IRBESARTAN
ANDA #203071		 SUPPL-5 IRBESARTAN PRINSTON INC Labeling Approval
08/13/2020 CARBIDOPA, LEVODOPA AND ENTACAPONE
ANDA #203424		 ORIG-1 CARBIDOPA; ENTACAPONE; LEVODOPA MYLAN Approval
08/13/2020 TEMOZOLOMIDE
ANDA #204639		 SUPPL-1 TEMOZOLOMIDE CHEMI SPA Labeling Approval
08/13/2020 MEMANTINE HYDROCHLORIDE
ANDA #206135		 SUPPL-1 MEMANTINE HYDROCHLORIDE APOTEX Labeling Approval
08/13/2020 DALFAMPRIDINE
ANDA #206646		 SUPPL-2 DALFAMPRIDINE HIKMA Labeling Approval
08/13/2020 DALFAMPRIDINE
ANDA #206811		 SUPPL-5 DALFAMPRIDINE AUROBINDO PHARMA Labeling Approval
08/13/2020 DICLOFENAC SODIUM
ANDA #208077		 SUPPL-11 DICLOFENAC SODIUM AMNEAL PHARMS Labeling Approval
08/13/2020 TERIFLUNOMIDE
ANDA #209663		 SUPPL-2 TERIFLUNOMIDE GLENMARK PHARMS Labeling Approval
08/14/2020 SUTENT
NDA #021938		 SUPPL-37 SUNITINIB MALATE CPPI CV Labeling Approval
08/14/2020 RISEDRONATE SODIUM
ANDA #077132		 SUPPL-9 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
08/14/2020 MONTELUKAST SODIUM
ANDA #202096		 SUPPL-22 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/14/2020 MONTELUKAST SODIUM
ANDA #202468		 SUPPL-24 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
08/14/2020 TEMOZOLOMIDE
ANDA #203490		 SUPPL-6 TEMOZOLOMIDE ANI PHARMS Labeling Approval
08/14/2020 MESALAMINE
ANDA #205654		 ORIG-1 MESALAMINE ACTAVIS MID ATLANTIC Approval
08/14/2020 DALFAMPRIDINE
ANDA #208292		 SUPPL-2 DALFAMPRIDINE SUN PHARM Labeling Approval
08/14/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208532		 SUPPL-2 DEXMEDETOMIDINE HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
08/14/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208532		 SUPPL-4 DEXMEDETOMIDINE HYDROCHLORIDE BAXTER HLTHCARE CORP Labeling Approval
08/14/2020 CLONIDINE HYDROCHLORIDE
ANDA #209675		 SUPPL-1 CLONIDINE HYDROCHLORIDE NOVAST LABS Labeling Approval
08/14/2020 DALFAMPRIDINE
ANDA #210158		 SUPPL-3 DALFAMPRIDINE MICRO LABS Labeling Approval
08/14/2020 UPNEEQ
NDA #212520		 SUPPL-2 OXYMETAZOLINE HYDROCHLORIDE RVL PHARMS Labeling Approval
08/14/2020 TAMOXIFEN CITRATE
ANDA #213358		 ORIG-1 TAMOXIFEN CITRATE EUGIA PHARMA Approval
08/14/2020 ENSPRYNG
BLA #761149		 ORIG-1 SATRALIZUMAB GENENTECH Approval
08/17/2020 CYCLOSET
NDA #020866		 SUPPL-12 BROMOCRIPTINE MESYLATE VEROSCIENCE Labeling Approval
08/17/2020 VOTRIENT
NDA #022465		 SUPPL-29 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-27 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-28 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-30 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-31 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-32 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 RIFAMPIN
ANDA #064150		 SUPPL-33 RIFAMPIN EPIC PHARMA LLC Labeling Approval
08/17/2020 DIAZEPAM
ANDA #070928		 SUPPL-17 DIAZEPAM HIKMA Labeling Approval
08/17/2020 RIFAMPIN
ANDA #090034		 SUPPL-13 RIFAMPIN LUPIN PHARMS Labeling Approval
08/17/2020 MORPHINE SULFATE
NDA #202515		 SUPPL-7 MORPHINE SULFATE HOSPIRA INC Manufacturing (CMC) Approval
08/17/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #204015		 SUPPL-1 FOSAPREPITANT DIMEGLUMINE MYLAN LABS LTD Labeling Approval
08/17/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #205780		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/17/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #205780		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE EUGIA PHARMA Labeling Approval
08/17/2020 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #207065		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL NAARI PTE LTD Approval
08/17/2020 DIMETHYL FUMARATE
ANDA #210531		 ORIG-1 DIMETHYL FUMARATE MYLAN Approval
08/17/2020 URSODIOL
ANDA #213555		 ORIG-1 URSODIOL CHARTWELL RX Approval
08/17/2020 URSODIOL
ANDA #213555		 SUPPL-1 URSODIOL CHARTWELL RX Approval
08/17/2020 GABAPENTIN
ANDA #213603		 ORIG-1 GABAPENTIN ZHEJIANG YONGTAI Approval
08/18/2020 ATELVIA
NDA #022560		 SUPPL-11 RISEDRONATE SODIUM APIL Labeling Approval
08/18/2020 VANCOCIN HYDROCHLORIDE
ANDA #062476		 SUPPL-26 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
08/18/2020 VANCOCIN HYDROCHLORIDE
ANDA #062476		 SUPPL-27 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
08/18/2020 VANCOCIN HYDROCHLORIDE
ANDA #062716		 SUPPL-19 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
08/18/2020 VANCOCIN HYDROCHLORIDE
ANDA #062716		 SUPPL-20 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
08/18/2020 VANCOCIN HYDROCHLORIDE
ANDA #062812		 SUPPL-33 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
08/18/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #078591		 SUPPL-5 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
08/18/2020 HYDROMORPHONE HYDROCHLORIDE
ANDA #078591		 SUPPL-12 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
08/18/2020 MONTELUKAST SODIUM
ANDA #079103		 SUPPL-16 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
08/18/2020 MONTELUKAST SODIUM
ANDA #079142		 SUPPL-16 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
08/18/2020 Xeomin
BLA #125360		 SUPPL-78 incobotulinumtoxinA MERZ PHARMS Approval
08/18/2020 RANOLAZINE
ANDA #201046		 SUPPL-5 RANOLAZINE CHARTWELL RX Manufacturing (CMC) Approval
08/18/2020 MONTELUKAST SODIUM
ANDA #202776		 SUPPL-10 MONTELUKAST SODIUM MYLAN PHARMS INC Labeling Approval
08/18/2020 INVOKANA
NDA #204042		 SUPPL-34 CANAGLIFLOZIN JANSSEN PHARMS Efficacy Approval
08/18/2020 INVOKAMET
NDA #204353		 SUPPL-39 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
08/18/2020 INVOKAMET XR
NDA #205879		 SUPPL-17 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
08/18/2020 VEMLIDY
NDA #208464		 SUPPL-10 TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
08/18/2020 VEMLIDY
NDA #208464		 SUPPL-11 TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
08/18/2020 RALOXIFENE HYDROCHLORIDE
ANDA #211324		 ORIG-1 RALOXIFENE HYDROCHLORIDE CADILA PHARMS LTD Approval
08/18/2020 NURTEC ODT
NDA #212728		 SUPPL-1 RIMEGEPANT SULFATE PFIZER Labeling Approval
08/18/2020 TOREMIFENE CITRATE
ANDA #212818		 ORIG-1 TOREMIFENE CITRATE MSN Approval
08/18/2020 ACARBOSE
ANDA #213821		 ORIG-1 ACARBOSE HANGZHOU ZHONGMEI Approval
08/19/2020 LAMICTAL
NDA #020241		 SUPPL-61 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/19/2020 LAMICTAL CD
NDA #020764		 SUPPL-54 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/19/2020 REMODULIN
NDA #021272		 SUPPL-30 TREPROSTINIL UNITED THERAP Manufacturing (CMC) Tentative Approval
08/19/2020 LAMICTAL ODT
NDA #022251		 SUPPL-25 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/19/2020 MOZOBIL
NDA #022311		 SUPPL-22 PLERIXAFOR GENZYME Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-16 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-17 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-19 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-20 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-25 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-27 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065397		 SUPPL-28 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065432		 SUPPL-16 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065432		 SUPPL-20 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065432		 SUPPL-21 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065432		 SUPPL-23 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-6 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-11 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #091554		 SUPPL-13 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #204107		 SUPPL-3 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #204107		 SUPPL-5 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Labeling Approval
08/19/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #205135		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #205694		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/19/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #205694		 SUPPL-7 VANCOMYCIN HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
08/19/2020 VARUBI
NDA #206500		 SUPPL-8 ROLAPITANT HYDROCHLORIDE TERSERA Labeling Approval
08/19/2020 VARUBI
NDA #208399		 SUPPL-4 ROLAPITANT HYDROCHLORIDE TERSERA Labeling Approval
08/19/2020 TERIFLUNOMIDE
ANDA #209710		 SUPPL-1 TERIFLUNOMIDE SANDOZ Labeling Approval
08/19/2020 TERIFLUNOMIDE
ANDA #209710		 SUPPL-2 TERIFLUNOMIDE SANDOZ Labeling Approval
08/19/2020 APIXABAN
ANDA #209810		 ORIG-1 APIXABAN IMPAX LABS Tentative Approval
08/19/2020 CYSTADROPS
NDA #211302		 ORIG-1 CYSTEAMINE HYDROCHLORIDE RECORDATI RARE Type 5 - New Formulation or New Manufacturer Approval
08/19/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #212504		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS GLW Approval
08/19/2020 OLOPATADINE HYDROCHLORIDE
ANDA #213757		 ORIG-1 OLOPATADINE HYDROCHLORIDE HIKMA Approval
08/19/2020 ATORVASTATIN CALCIUM
ANDA #213853		 ORIG-1 ATORVASTATIN CALCIUM UMEDICA Approval
08/20/2020 ALDACTAZIDE
NDA #012616		 SUPPL-80 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER Labeling Approval
08/20/2020 DYAZIDE
NDA #016042		 SUPPL-79 HYDROCHLOROTHIAZIDE; TRIAMTERENE GLAXOSMITHKLINE LLC Labeling Approval
08/20/2020 LOPRESSOR HCT
NDA #018303		 SUPPL-41 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE VALIDUS PHARMS Labeling Approval
08/20/2020 MAXZIDE
NDA #019129		 SUPPL-56 HYDROCHLOROTHIAZIDE; TRIAMTERENE AUROBINDO PHARMA USA Labeling Approval
08/20/2020 MAXZIDE-25
NDA #019129		 SUPPL-56 HYDROCHLOROTHIAZIDE; TRIAMTERENE AUROBINDO PHARMA USA Labeling Approval
08/20/2020 VASERETIC
NDA #019221		 SUPPL-50 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE BAUSCH Labeling Approval
08/20/2020 ZESTORETIC
NDA #019888		 SUPPL-69 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
08/20/2020 LOTENSIN HCT
NDA #020033		 SUPPL-63 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Labeling Approval
08/20/2020 ACCURETIC
NDA #020125		 SUPPL-27 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
08/20/2020 ZIAC
NDA #020186		 SUPPL-35 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Labeling Approval
08/20/2020 HYZAAR
NDA #020387		 SUPPL-66 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ORGANON Labeling Approval
08/20/2020 HYZAAR
NDA #020387		 SUPPL-67 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ORGANON Labeling Approval
08/20/2020 MICROZIDE
NDA #020504		 SUPPL-26 HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Labeling Approval
08/20/2020 AVALIDE
NDA #020758		 SUPPL-79 HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US Labeling Approval
08/20/2020 DIOVAN HCT
NDA #020818		 SUPPL-80 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
08/20/2020 ATACAND HCT
NDA #021093		 SUPPL-21 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
08/20/2020 MICARDIS HCT
NDA #021162		 SUPPL-45 HYDROCHLOROTHIAZIDE; TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
08/20/2020 MIRENA
NDA #021225		 SUPPL-40 LEVONORGESTREL BAYER HLTHCARE Efficacy Approval
08/20/2020 BENICAR HCT
NDA #021532		 SUPPL-37 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
08/20/2020 DUTOPROL
NDA #021956		 SUPPL-12 HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE CONCORDIA Labeling Approval
08/20/2020 EXFORGE HCT
NDA #022314		 SUPPL-35 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040412		 SUPPL-23 HYDROCHLOROTHIAZIDE PRINSTON INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040702		 SUPPL-12 HYDROCHLOROTHIAZIDE LEADING Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040707		 SUPPL-17 HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040735		 SUPPL-5 HYDROCHLOROTHIAZIDE MYLAN PHARMS INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040770		 SUPPL-5 HYDROCHLOROTHIAZIDE MYLAN PHARMS INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040780		 SUPPL-20 HYDROCHLOROTHIAZIDE AUROBINDO PHARMA Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040807		 SUPPL-16 HYDROCHLOROTHIAZIDE IPCA LABS LTD Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040809		 SUPPL-8 HYDROCHLOROTHIAZIDE JUBILANT CADISTA Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040810		 SUPPL-9 HYDROCHLOROTHIAZIDE SUN PHARM INDS INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040857		 SUPPL-7 HYDROCHLOROTHIAZIDE SUN PHARM INDS INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #040907		 SUPPL-18 HYDROCHLOROTHIAZIDE UNICHEM Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070182		 SUPPL-30 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070183		 SUPPL-29 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070265		 SUPPL-47 HYDROCHLOROTHIAZIDE; METHYLDOPA RISING Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070543		 SUPPL-26 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070544		 SUPPL-27 HYDROCHLOROTHIAZIDE; METHYLDOPA CHARTWELL RX Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070612		 SUPPL-28 HYDROCHLOROTHIAZIDE; METHYLDOPA STRIDES PHARMA Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070613		 SUPPL-28 HYDROCHLOROTHIAZIDE; METHYLDOPA STRIDES PHARMA Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070614		 SUPPL-27 HYDROCHLOROTHIAZIDE; METHYLDOPA STRIDES PHARMA Labeling Approval
08/20/2020 METHYLDOPA AND HYDROCHLOROTHIAZIDE
ANDA #070616		 SUPPL-27 HYDROCHLOROTHIAZIDE; METHYLDOPA STRIDES PHARMA Labeling Approval
08/20/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070705		 SUPPL-23 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS Labeling Approval
08/20/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070947		 SUPPL-35 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE RISING Labeling Approval
08/20/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071060		 SUPPL-16 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/20/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071061		 SUPPL-16 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/20/2020 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #071111		 SUPPL-34 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE BARR Labeling Approval
08/20/2020 PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #072043		 SUPPL-17 HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE ANI PHARMS Labeling Approval
08/20/2020 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #073209		 SUPPL-27 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE RISING Labeling Approval
08/20/2020 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #073334		 SUPPL-17 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE WATSON LABS Labeling Approval
08/20/2020 AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #073357		 SUPPL-9 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/20/2020 CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #074788		 SUPPL-3 CAPTOPRIL; HYDROCHLOROTHIAZIDE STRIDES PHARMA Labeling Approval
08/20/2020 CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #074827		 SUPPL-19 CAPTOPRIL; HYDROCHLOROTHIAZIDE COSETTE Labeling Approval
08/20/2020 CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #074896		 SUPPL-31 CAPTOPRIL; HYDROCHLOROTHIAZIDE RISING Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075776		 SUPPL-44 HYDROCHLOROTHIAZIDE; LISINOPRIL CHARTWELL RX Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075926		 SUPPL-16 HYDROCHLOROTHIAZIDE; LISINOPRIL EPIC PHARMA LLC Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076113		 SUPPL-38 HYDROCHLOROTHIAZIDE; LISINOPRIL MYLAN Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076230		 SUPPL-19 HYDROCHLOROTHIAZIDE; LISINOPRIL PRINSTON INC Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-31 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #076608		 SUPPL-6 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-20 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #076961		 SUPPL-19 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
08/20/2020 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076980		 SUPPL-15 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TEVA Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #077144		 SUPPL-2 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
08/20/2020 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-27 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #079025		 SUPPL-4 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE AVET LIFESCIENCES Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #079245		 SUPPL-12 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE AUROBINDO PHARMA Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #081190		 SUPPL-6 HYDROCHLOROTHIAZIDE WATSON LABS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #083177		 SUPPL-229 HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #083965		 SUPPL-97 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #083972		 SUPPL-175 HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #084324		 SUPPL-70 HYDROCHLOROTHIAZIDE LANNETT CO INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #084325		 SUPPL-49 HYDROCHLOROTHIAZIDE LANNETT CO INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #084878		 SUPPL-50 HYDROCHLOROTHIAZIDE HIKMA INTL PHARMS Labeling Approval
08/20/2020 CAM-AP-ES
ANDA #084897		 SUPPL-36 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE CHARTWELL RX Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #084912		 SUPPL-71 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #085054		 SUPPL-41 HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #085182		 SUPPL-38 HYDROCHLOROTHIAZIDE HERITAGE PHARMS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #085208		 SUPPL-39 HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #085683		 SUPPL-58 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #087059		 SUPPL-20 HYDROCHLOROTHIAZIDE OXFORD PHARMS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #087060		 SUPPL-2 HYDROCHLOROTHIAZIDE DAVA PHARMS INC Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #087068		 SUPPL-22 HYDROCHLOROTHIAZIDE OXFORD PHARMS Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #087565		 SUPPL-27 HYDROCHLOROTHIAZIDE CHARTWELL RX Labeling Approval
08/20/2020 HYDRA-ZIDE
ANDA #088946		 SUPPL-22 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE STRIDES PHARMA Labeling Approval
08/20/2020 HYDRA-ZIDE
ANDA #088957		 SUPPL-22 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE STRIDES PHARMA Labeling Approval
08/20/2020 HYDRA-ZIDE
ANDA #088961		 SUPPL-22 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE STRIDES PHARMA Labeling Approval
08/20/2020 GABAPENTIN
ANDA #090007		 SUPPL-3 GABAPENTIN MARKSANS PHARMA Labeling Approval
08/20/2020 GABAPENTIN
ANDA #090007		 SUPPL-4 GABAPENTIN MARKSANS PHARMA Labeling Approval
08/20/2020 GABAPENTIN
ANDA #090007		 SUPPL-5 GABAPENTIN MARKSANS PHARMA Labeling Approval
08/20/2020 GABAPENTIN
ANDA #090007		 SUPPL-6 GABAPENTIN MARKSANS PHARMA Labeling Approval
08/20/2020 GABAPENTIN
ANDA #090007		 SUPPL-8 GABAPENTIN MARKSANS PHARMA Labeling Approval
08/20/2020 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #090096		 SUPPL-3 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
08/20/2020 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #090228		 SUPPL-9 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE INVAGEN PHARMS Labeling Approval
08/20/2020 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #090718		 SUPPL-7 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE GLENMARK PHARMS Labeling Approval
08/20/2020 TOPOTECAN HYDROCHLORIDE
ANDA #091089		 SUPPL-6 TOPOTECAN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/20/2020 VINORELBINE TARTRATE
ANDA #091106		 SUPPL-9 VINORELBINE TARTRATE JIANGSU HANSOH PHARM Labeling Approval
08/20/2020 TOPOTECAN HYDROCHLORIDE
ANDA #091199		 SUPPL-4 TOPOTECAN HYDROCHLORIDE TEYRO LABS Labeling Approval
08/20/2020 TOPOTECAN HYDROCHLORIDE
ANDA #091284		 SUPPL-1 TOPOTECAN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
08/20/2020 ARZERRA
BLA #125326		 SUPPL-70 OFATUMUMAB NOVARTIS Approval
08/20/2020 KESIMPTA
BLA #125326		 SUPPL-70 OFATUMUMAB NOVARTIS Approval
08/20/2020 LETROZOLE
ANDA #200161		 SUPPL-6 LETROZOLE NATCO PHARMA LTD Manufacturing (CMC) Approval
08/20/2020 TRIBENZOR
NDA #200175		 SUPPL-37 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Labeling Approval
08/20/2020 VINORELBINE TARTRATE
ANDA #202017		 SUPPL-1 VINORELBINE TARTRATE DR REDDYS Labeling Approval
08/20/2020 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #202150		 SUPPL-4 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE HERITAGE PHARMS Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #202319		 SUPPL-15 LANSOPRAZOLE PERRIGO R AND D Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #202319		 SUPPL-20 LANSOPRAZOLE PERRIGO R AND D Labeling Approval
08/20/2020 TOPOTECAN HYDROCHLORIDE
ANDA #202351		 SUPPL-5 TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #202556		 SUPPL-6 HYDROCHLOROTHIAZIDE ACCORD HLTHCARE Labeling Approval
08/20/2020 KYPROLIS
NDA #202714		 SUPPL-30 CARFILZOMIB ONYX PHARMS AMGEN Efficacy Approval
08/20/2020 HYDROCHLOROTHIAZIDE
ANDA #203018		 SUPPL-7 HYDROCHLOROTHIAZIDE SCIEGEN PHARMS INC Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #203203		 SUPPL-2 LANSOPRAZOLE XIROMED Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #203203		 SUPPL-4 LANSOPRAZOLE XIROMED Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #203203		 SUPPL-5 LANSOPRAZOLE XIROMED Labeling Approval
08/20/2020 LANSOPRAZOLE
ANDA #203203		 SUPPL-6 LANSOPRAZOLE XIROMED Labeling Approval
08/20/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #206616		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE HIKMA PHARMS Labeling Approval
08/20/2020 VINORELBINE TARTRATE
ANDA #208997		 SUPPL-2 VINORELBINE TARTRATE NOVAST LABS Labeling Approval
08/20/2020 DOPTELET
NDA #210238		 SUPPL-4 AVATROMBOPAG MALEATE AKARX INC Labeling Approval
08/20/2020 KETOROLAC TROMETHAMINE
ANDA #211445		 ORIG-1 KETOROLAC TROMETHAMINE NEPHRON Approval
08/20/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #212957		 ORIG-1 FOSAPREPITANT DIMEGLUMINE NAVINTA LLC Approval
08/20/2020 DAPTOMYCIN
ANDA #213425		 ORIG-1 DAPTOMYCIN BE PHARMS Approval
08/20/2020 URSODIOL
ANDA #213504		 ORIG-1 URSODIOL STRIDES PHARMA Approval
08/20/2020 DARZALEX
BLA #761036		 SUPPL-29 DARATUMUMAB JANSSEN BIOTECH Approval
08/20/2020 LUMOXITI
BLA #761104		 SUPPL-3 MOXETUMOMAB PASUDOTOX-TDFK INNATE PHARMA Approval
08/21/2020 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-82 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/21/2020 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-82 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
08/21/2020 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-82 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
08/21/2020 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-82 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
08/21/2020 CEFDINIR
ANDA #065418		 SUPPL-9 CEFDINIR ANDA REPOSITORY Labeling Approval
08/21/2020 BROMOCRIPTINE MESYLATE
ANDA #076962		 SUPPL-10 BROMOCRIPTINE MESYLATE AUROBINDO PHARMA USA Labeling Approval
08/21/2020 BROMOCRIPTINE MESYLATE
ANDA #077226		 SUPPL-11 BROMOCRIPTINE MESYLATE MYLAN Labeling Approval
08/21/2020 BROMOCRIPTINE MESYLATE
ANDA #077646		 SUPPL-7 BROMOCRIPTINE MESYLATE PADAGIS US Labeling Approval
08/21/2020 GABAPENTIN
ANDA #078428		 SUPPL-33 GABAPENTIN AMNEAL PHARMS NY Labeling Approval
08/21/2020 GABAPENTIN
ANDA #078428		 SUPPL-36 GABAPENTIN AMNEAL PHARMS NY Labeling Approval
08/21/2020 GABAPENTIN
ANDA #078428		 SUPPL-43 GABAPENTIN AMNEAL PHARMS NY Labeling Approval
08/21/2020 TYBOST
NDA #203094		 SUPPL-15 COBICISTAT GILEAD SCIENCES INC Labeling Approval
08/21/2020 STRIBILD
NDA #203100		 SUPPL-35 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
08/21/2020 PEMETREXED
NDA #208419		 ORIG-1 PEMETREXED ACTAVIS Type 2 - New Active Ingredient Approval
08/21/2020 ERTAPENEM SODIUM
ANDA #208790		 SUPPL-1 ERTAPENEM SODIUM ACS DOBFAR SPA Labeling Approval
08/21/2020 ERTAPENEM SODIUM
ANDA #208790		 SUPPL-2 ERTAPENEM SODIUM ACS DOBFAR SPA Labeling Approval
08/21/2020 VUMERITY
NDA #211855		 SUPPL-2 DIROXIMEL FUMARATE BIOGEN INC Labeling Approval
08/21/2020 RAMELTEON
ANDA #213186		 ORIG-1 RAMELTEON GRANULES Approval
08/21/2020 POTASSIUM CHLORIDE
ANDA #213588		 ORIG-1 POTASSIUM CHLORIDE BRECKENRIDGE Approval
08/24/2020 KETALAR
NDA #016812		 SUPPL-46 KETAMINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
08/24/2020 LOPRESSOR
NDA #018704		 SUPPL-27 METOPROLOL TARTRATE NOVARTIS Labeling Approval
08/24/2020 LOPRESSOR
NDA #018704		 SUPPL-28 METOPROLOL TARTRATE NOVARTIS Labeling Approval
08/24/2020 IRINOTECAN HYDROCHLORIDE
ANDA #200771		 SUPPL-6 IRINOTECAN HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
08/24/2020 LIDOCAINE
ANDA #206463		 ORIG-1 LIDOCAINE AMNEAL Approval
08/24/2020 BEVYXXA
NDA #208383		 SUPPL-7 BETRIXABAN PORTOLA PHARMS INC Labeling Approval
08/24/2020 ALBUTEROL SULFATE
ANDA #209954		 ORIG-1 ALBUTEROL SULFATE LUPIN Approval
08/24/2020 PACLITAXEL
ANDA #213434		 ORIG-1 PACLITAXEL MSN Approval
08/24/2020 DESONIDE
ANDA #213632		 ORIG-1 DESONIDE ALEMBIC Approval
08/24/2020 AMPHETAMINE SULFATE
ANDA #213763		 ORIG-1 AMPHETAMINE SULFATE NOVAST LABS Approval
08/24/2020 METHOTREXATE
NDA #214121		 ORIG-1 METHOTREXATE ACCORD HLTHCARE Type 5 - New Formulation or New Manufacturer Approval
08/25/2020 ARIXTRA
NDA #021345		 SUPPL-43 FONDAPARINUX SODIUM MYLAN IRELAND LTD Labeling Approval
08/25/2020 ABRAXANE
NDA #021660		 SUPPL-47 PACLITAXEL BRISTOL-MYERS Labeling Approval
08/25/2020 BETAMETHASONE DIPROPIONATE
ANDA #076592		 SUPPL-5 BETAMETHASONE DIPROPIONATE PADAGIS ISRAEL Labeling Approval
08/25/2020 BETAMETHASONE DIPROPIONATE
ANDA #076592		 SUPPL-7 BETAMETHASONE DIPROPIONATE PADAGIS ISRAEL Labeling Approval
08/25/2020 OXCARBAZEPINE
ANDA #077802		 SUPPL-13 OXCARBAZEPINE GLENMARK PHARMS LTD Labeling Approval
08/25/2020 OXCARBAZEPINE
ANDA #077802		 SUPPL-15 OXCARBAZEPINE GLENMARK PHARMS LTD Labeling Approval
08/25/2020 OXCARBAZEPINE
ANDA #077802		 SUPPL-17 OXCARBAZEPINE GLENMARK PHARMS LTD Labeling Approval
08/25/2020 CARVEDILOL
ANDA #078227		 SUPPL-13 CARVEDILOL SANDOZ Labeling Approval
08/25/2020 ZOLPIDEM TARTRATE
ANDA #078616		 SUPPL-12 ZOLPIDEM TARTRATE STRIDES PHARMA Labeling Approval
08/25/2020 ZOLPIDEM TARTRATE
ANDA #078616		 SUPPL-13 ZOLPIDEM TARTRATE STRIDES PHARMA Labeling Approval
08/25/2020 ZOLPIDEM TARTRATE
ANDA #078616		 SUPPL-16 ZOLPIDEM TARTRATE STRIDES PHARMA Labeling Approval
08/25/2020 FENOFIBRATE
ANDA #201748		 SUPPL-2 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
08/25/2020 FENOFIBRATE
ANDA #201748		 SUPPL-3 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
08/25/2020 FENOFIBRATE
ANDA #201748		 SUPPL-4 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
08/25/2020 FENOFIBRATE
ANDA #201748		 SUPPL-6 FENOFIBRATE SUN PHARM INDS LTD Labeling Approval
08/25/2020 SUMATRIPTAN SUCCINATE
ANDA #202758		 SUPPL-5 SUMATRIPTAN SUCCINATE EUGIA PHARMA Labeling Approval
08/25/2020 SUMATRIPTAN SUCCINATE
ANDA #202758		 SUPPL-6 SUMATRIPTAN SUCCINATE EUGIA PHARMA Labeling Approval
08/25/2020 RIFAMPIN
ANDA #204101		 SUPPL-9 RIFAMPIN AVET LIFESCIENCES Labeling Approval
08/25/2020 RYANODEX
NDA #205579		 SUPPL-7 DANTROLENE SODIUM EAGLE PHARMS Labeling Approval
08/25/2020 SILDENAFIL CITRATE
ANDA #209302		 ORIG-1 SILDENAFIL CITRATE UMEDICA Approval
08/25/2020 DAYVIGO
NDA #212028		 SUPPL-2 LEMBOREXANT EISAI INC Labeling Approval
08/25/2020 SODIUM NITROPRUSSIDE
ANDA #214199		 ORIG-1 SODIUM NITROPRUSSIDE HAINAN POLY PHARM Approval
08/26/2020 CUBICIN
NDA #021572		 SUPPL-63 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/26/2020 CUBICIN
NDA #021572		 SUPPL-64 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/26/2020 CUBICIN RF
NDA #021572		 SUPPL-63 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/26/2020 CUBICIN RF
NDA #021572		 SUPPL-64 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
08/26/2020 CARBAGLU
NDA #022562		 SUPPL-12 CARGLUMIC ACID RECORDATI RARE Labeling Approval
08/26/2020 PILOCARPINE HYDROCHLORIDE
ANDA #076963		 SUPPL-9 PILOCARPINE HYDROCHLORIDE INNOGENIX Labeling Approval
08/26/2020 CALCITONIN-SALMON
ANDA #076979		 SUPPL-14 CALCITONIN SALMON ENDO OPERATIONS Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077747		 SUPPL-10 OXCARBAZEPINE RUBICON Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077747		 SUPPL-11 OXCARBAZEPINE RUBICON Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077794		 SUPPL-13 OXCARBAZEPINE SUN PHARM INDS Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077794		 SUPPL-15 OXCARBAZEPINE SUN PHARM INDS Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077794		 SUPPL-19 OXCARBAZEPINE SUN PHARM INDS Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077795		 SUPPL-11 OXCARBAZEPINE HIKMA Labeling Approval
08/26/2020 OXCARBAZEPINE
ANDA #077795		 SUPPL-12 OXCARBAZEPINE HIKMA Labeling Approval
08/26/2020 PROPYLTHIOURACIL
ANDA #080154		 SUPPL-43 PROPYLTHIOURACIL QUAGEN Labeling Approval
08/26/2020 ROPINIROLE HYDROCHLORIDE
ANDA #204022		 SUPPL-1 ROPINIROLE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
08/26/2020 ROPINIROLE HYDROCHLORIDE
ANDA #204022		 SUPPL-2 ROPINIROLE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
08/26/2020 FOSAPREPITANT DIMEGLUMINE
ANDA #204025		 ORIG-1 FOSAPREPITANT DIMEGLUMINE ACCORD HLTHCARE Approval
08/26/2020 SYMJEPI
NDA #207534		 SUPPL-8 EPINEPHRINE ADAMIS PHARMS CORP Labeling Approval
08/26/2020 INGENOL MEBUTATE
ANDA #209018		 SUPPL-1 INGENOL MEBUTATE PADAGIS ISRAEL Labeling Approval
08/26/2020 INGENOL MEBUTATE
ANDA #209019		 SUPPL-1 INGENOL MEBUTATE PADAGIS ISRAEL Labeling Approval
08/26/2020 METHOTREXATE SODIUM
ANDA #210454		 SUPPL-1 METHOTREXATE SODIUM EUGIA PHARMA Labeling Approval
08/26/2020 METHOTREXATE SODIUM
ANDA #210454		 SUPPL-2 METHOTREXATE SODIUM EUGIA PHARMA Labeling Approval
08/26/2020 STERILE WATER FOR INJECTION
ANDA #211188		 SUPPL-2 STERILE WATER FOR INJECTION MEDEFIL INC Labeling Approval
08/26/2020 DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ANDA #211194		 ORIG-1 DEXTROSE; SODIUM CHLORIDE FRESENIUS KABI USA Approval
08/26/2020 EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212354		 ORIG-1 EMPAGLIFLOZIN; LINAGLIPTIN KINAPSE LIMITED Tentative Approval
08/26/2020 WINLEVI
NDA #213433		 ORIG-1 CLASCOTERONE SUN PHARM Type 1 - New Molecular Entity Approval
08/27/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062663		 SUPPL-86 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/27/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #062663		 SUPPL-90 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
08/27/2020 FLUOXETINE HYDROCHLORIDE
ANDA #202729		 ORIG-1 FLUOXETINE HYDROCHLORIDE ACCORD HLTHCARE Approval
08/27/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #204360		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE HIKMA Labeling Approval
08/27/2020 SOVALDI
NDA #204671		 SUPPL-18 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
08/27/2020 ARISTADA
NDA #207533		 SUPPL-17 ARIPIPRAZOLE LAUROXIL ALKERMES INC Labeling Approval
08/27/2020 ULTRAVATE
NDA #208183		 SUPPL-2 HALOBETASOL PROPIONATE MICAL PHARMS Efficacy Approval
08/27/2020 NUMBRINO
NDA #209575		 SUPPL-2 COCAINE HYDROCHLORIDE OMNIVIUM PHARMS Labeling Approval
08/27/2020 ARISTADA INITIO KIT
NDA #209830		 SUPPL-5 ARIPIPRAZOLE LAUROXIL ALKERMES INC Labeling Approval
08/27/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #212571		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE MYLAN LABS LTD Approval
08/28/2020 ALOPRIM
NDA #020298		 SUPPL-10 ALLOPURINOL SODIUM MYLAN Labeling Approval
08/28/2020 LEXAPRO
NDA #021323		 SUPPL-52 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
08/28/2020 LEXAPRO
NDA #021365		 SUPPL-37 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
08/28/2020 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-78 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/28/2020 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-30 DOXORUBICIN HYDROCHLORIDE PFIZER Labeling Approval
08/28/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065455		 SUPPL-6 VANCOMYCIN HYDROCHLORIDE HOSPIRA INC Labeling Approval
08/28/2020 VANCOMYCIN HYDROCHLORIDE
ANDA #065455		 SUPPL-14 VANCOMYCIN HYDROCHLORIDE HOSPIRA INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #077953		 SUPPL-10 RISPERIDONE APOTEX INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #077953		 SUPPL-11 RISPERIDONE APOTEX INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #077953		 SUPPL-12 RISPERIDONE APOTEX INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #077953		 SUPPL-13 RISPERIDONE APOTEX INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #077953		 SUPPL-14 RISPERIDONE APOTEX INC Labeling Approval
08/28/2020 RISPERIDONE
ANDA #078040		 SUPPL-27 RISPERIDONE ZYDUS PHARMS USA INC Labeling Approval
08/28/2020 FOSPHENYTOIN SODIUM
ANDA #078052		 SUPPL-15 FOSPHENYTOIN SODIUM FRESENIUS KABI USA Labeling Approval
08/28/2020 OXCARBAZEPINE
ANDA #078069		 SUPPL-12 OXCARBAZEPINE BRECKENRIDGE PHARM Labeling Approval
08/28/2020 OXCARBAZEPINE
ANDA #078069		 SUPPL-13 OXCARBAZEPINE BRECKENRIDGE PHARM Labeling Approval
08/28/2020 RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #088570		 SUPPL-23 HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE SUN PHARM INDUSTRIES Labeling Approval
08/28/2020 RITUXAN
BLA #103705		 SUPPL-5460 RITUXIMAB GENENTECH Approval
08/28/2020 XARACOLL
NDA #209511		 ORIG-1 BUPIVACAINE HYDROCHLORIDE INNOCOLL PHARMS Type 3 - New Dosage Form and Type 4 - New Combination Approval
08/28/2020 CLOBETASOL PROPIONATE
ANDA #212982		 ORIG-1 CLOBETASOL PROPIONATE ENCUBE Approval
08/28/2020 SOGROYA
BLA #761156		 ORIG-1 SOMAPACITAN-BECO NOVO NORDISK INC Approval
08/31/2020 LAMICTAL
NDA #020241		 SUPPL-62 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/31/2020 LAMICTAL CD
NDA #020764		 SUPPL-55 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/31/2020 LAMICTAL XR
NDA #022115		 SUPPL-27 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/31/2020 LAMICTAL ODT
NDA #022251		 SUPPL-26 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
08/31/2020 QUETIAPINE FUMARATE
ANDA #077745		 SUPPL-13 QUETIAPINE FUMARATE TEVA PHARMS Labeling Approval
08/31/2020 BLISOVI FE 1/20
ANDA #201584		 SUPPL-16 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN LTD Manufacturing (CMC) Approval
08/31/2020 INBRIJA
NDA #209184		 SUPPL-5 LEVODOPA ACORDA Labeling Approval
08/31/2020 INBRIJA
NDA #209184		 SUPPL-7 LEVODOPA ACORDA Labeling Approval
08/31/2020 MEMANTINE HYDROCHLORIDE
ANDA #210319		 ORIG-1 MEMANTINE HYDROCHLORIDE SETON PHARMS Approval
08/31/2020 DAPTOMYCIN
ANDA #211403		 ORIG-1 DAPTOMYCIN DR REDDYS Approval
08/31/2020 XCOPRI
NDA #212839		 SUPPL-1 CENOBAMATE SK LIFE Labeling Approval
08/31/2020 CHLORPROMAZINE HYDROCHLORIDE
ANDA #213590		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE APPCO Approval
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