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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 2024

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 May 20, 2024.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/2024 AMOXIL
NDA #050542		 SUPPL-32 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '250'
NDA #050564		 SUPPL-60 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '500'
NDA #050564		 SUPPL-60 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '125'
NDA #050575		 SUPPL-51 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '250'
NDA #050575		 SUPPL-51 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '125'
NDA #050597		 SUPPL-52 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '250'
NDA #050597		 SUPPL-52 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 UNASYN
NDA #050608		 SUPPL-53 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
05/01/2024 ZOSYN
NDA #050684		 SUPPL-104 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WYETH PHARMS Labeling Approval
05/01/2024 AUGMENTIN '875'
NDA #050720		 SUPPL-37 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '200'
NDA #050725		 SUPPL-36 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '400'
NDA #050725		 SUPPL-36 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '200'
NDA #050726		 SUPPL-27 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN '400'
NDA #050726		 SUPPL-27 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 ZOSYN IN PLASTIC CONTAINER
NDA #050750		 SUPPL-51 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM BAXTER HLTHCARE CORP Labeling Approval
05/01/2024 AMOXIL
NDA #050754		 SUPPL-22 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN ES-600
NDA #050755		 SUPPL-29 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 AMOXIL
NDA #050760		 SUPPL-23 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AMOXIL
NDA #050761		 SUPPL-19 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AUGMENTIN XR
NDA #050785		 SUPPL-18 AMOXICILLIN; CLAVULANATE POTASSIUM US ANTIBIOTICS Labeling Approval
05/01/2024 MOXATAG
NDA #050813		 SUPPL-10 AMOXICILLIN PRAGMA Labeling Approval
05/01/2024 OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
NDA #050824		 SUPPL-13 AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE CUMBERLAND Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #061395		 SUPPL-52 AMPICILLIN SODIUM SANDOZ Labeling Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #061502		 SUPPL-140 AMPICILLIN/AMPICILLIN TRIHYDRATE CHARTWELL RX Labeling Approval
05/01/2024 PROBAMPACIN
ANDA #061741		 SUPPL-1 AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID COSETTE Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #061926		 SUPPL-136 AMOXICILLIN TEVA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #061931		 SUPPL-60 AMOXICILLIN TEVA Labeling Approval
05/01/2024 AMOXICILLIN PEDIATRIC
ANDA #061931		 SUPPL-60 AMOXICILLIN TEVA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #062058		 SUPPL-15 AMOXICILLIN CHARTWELL Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #062059		 SUPPL-6 AMOXICILLIN CHARTWELL RX Labeling Approval
05/01/2024 AMOXIL
ANDA #062216		 SUPPL-44 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AMOXIL
ANDA #062226		 SUPPL-40 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 LAROTID
ANDA #062226		 SUPPL-40 AMOXICILLIN US ANTIBIOTICS Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #062692		 SUPPL-2 AMPICILLIN SODIUM HIKMA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #062719		 SUPPL-16 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #062738		 SUPPL-33 AMPICILLIN SODIUM SANDOZ Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #062772		 SUPPL-17 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #062797		 SUPPL-13 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #062881		 SUPPL-29 AMOXICILLIN STRIDES PHARMA Labeling Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #062882		 SUPPL-17 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #062883		 SUPPL-15 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #062884		 SUPPL-26 AMOXICILLIN STRIDES PHARMA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #062927		 SUPPL-29 AMOXICILLIN DAVA PHARMS INC Labeling Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #062982		 SUPPL-16 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #063142		 SUPPL-18 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #064013		 SUPPL-64 AMOXICILLIN TEVA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #064076		 SUPPL-38 AMOXICILLIN SANDOZ Labeling Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #064082		 SUPPL-22 AMPICILLIN/AMPICILLIN TRIHYDRATE SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #064139		 SUPPL-16 AMOXICILLIN CHARTWELL RX Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065056		 SUPPL-26 AMOXICILLIN TEVA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065063		 SUPPL-51 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065064		 SUPPL-50 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065065		 SUPPL-35 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065066		 SUPPL-50 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065089		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065093		 SUPPL-33 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065096		 SUPPL-39 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA PHARMS USA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065098		 SUPPL-25 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065101		 SUPPL-38 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
05/01/2024 PIPERACILLIN
ANDA #065114		 SUPPL-18 PIPERACILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065117		 SUPPL-34 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065119		 SUPPL-33 AMOXICILLIN TEVA Labeling Approval
05/01/2024 PIPERACILLIN
ANDA #065157		 SUPPL-15 PIPERACILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162		 SUPPL-40 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065189		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065191		 SUPPL-35 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065228		 SUPPL-20 AMOXICILLIN SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065255		 SUPPL-28 AMOXICILLIN HIKMA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065256		 SUPPL-25 AMOXICILLIN AUROBINDO Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065271		 SUPPL-25 AMOXICILLIN AUROBINDO Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065291		 SUPPL-33 AMOXICILLIN HIKMA PHARMS Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065317		 SUPPL-4 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065322		 SUPPL-39 AMOXICILLIN HIKMA Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065325		 SUPPL-35 AMOXICILLIN HIKMA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065333		 SUPPL-4 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065334		 SUPPL-25 AMOXICILLIN AUROBINDO Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065344		 SUPPL-8 AMOXICILLIN CHARTWELL RX Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-44 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #065363		 SUPPL-47 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373		 SUPPL-23 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373		 SUPPL-27 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373		 SUPPL-30 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065378		 SUPPL-19 AMOXICILLIN SANDOZ Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #065387		 SUPPL-19 AMOXICILLIN SANDOZ Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #065458		 SUPPL-16 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM STERISCIENCE Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #065493		 SUPPL-11 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #065498		 SUPPL-26 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EUGIA PHARMA SPECLTS Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #065499		 SUPPL-13 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #065523		 SUPPL-30 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #090227		 SUPPL-19 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #090354		 SUPPL-7 AMPICILLIN SODIUM ANTIBIOTICE Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #090498		 SUPPL-24 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #090581		 SUPPL-5 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #090583		 SUPPL-5 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #090884		 SUPPL-3 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #090889		 SUPPL-3 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
05/01/2024 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-12 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #201025		 SUPPL-10 AMPICILLIN SODIUM STERISCIENCE Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201090		 SUPPL-14 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201091		 SUPPL-13 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #201404		 SUPPL-8 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
05/01/2024 AMPICILLIN SODIUM
ANDA #202198		 SUPPL-7 AMPICILLIN SODIUM STERISCIENCE Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-35 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #203719		 SUPPL-12 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM FRESENIUS KABI Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #203720		 SUPPL-11 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM FRESENIUS KABI Labeling Approval
05/01/2024 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #203972		 SUPPL-14 DEXMEDETOMIDINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
05/01/2024 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #203972		 SUPPL-15 DEXMEDETOMIDINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #204030		 SUPPL-13 AMOXICILLIN AUROBINDO PHARMA LTD Labeling Approval
05/01/2024 OXYMORPHONE HYDROCHLORIDE
ANDA #204459		 SUPPL-7 OXYMORPHONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
05/01/2024 OXYMORPHONE HYDROCHLORIDE
ANDA #204459		 SUPPL-8 OXYMORPHONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
05/01/2024 OXYMORPHONE HYDROCHLORIDE
ANDA #204459		 SUPPL-9 OXYMORPHONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
05/01/2024 OXYMORPHONE HYDROCHLORIDE
ANDA #204459		 SUPPL-10 OXYMORPHONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
05/01/2024 ETODOLAC
ANDA #204729		 ORIG-1 ETODOLAC IPCA LABS LTD Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #204755		 SUPPL-12 AMOXICILLIN; CLAVULANATE POTASSIUM MICRO LABS LTD INDIA Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #204959		 SUPPL-13 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SHANDONG Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205187		 SUPPL-4 AMOXICILLIN; CLAVULANATE POTASSIUM MICRO LABS LTD INDIA Labeling Approval
05/01/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205707		 SUPPL-12 AMOXICILLIN; CLAVULANATE POTASSIUM MICRO LABS LTD INDIA Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #206996		 SUPPL-9 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WOCKHARDT BIO AG Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #207146		 SUPPL-9 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM WOCKHARDT BIO AG Labeling Approval
05/01/2024 AMOXICILLIN
ANDA #207471		 SUPPL-2 AMOXICILLIN MICRO LABS Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #207847		 SUPPL-15 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM PROVEPHARM SAS Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #207848		 SUPPL-15 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM PROVEPHARM SAS Labeling Approval
05/01/2024 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208266		 SUPPL-9 DEXMEDETOMIDINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #208674		 SUPPL-5 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SAGENT PHARMS INC Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #208675		 SUPPL-5 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SAGENT PHARMS INC Labeling Approval
05/01/2024 MYCOPHENOLATE MOFETIL
ANDA #212634		 SUPPL-1 MYCOPHENOLATE MOFETIL STRIDES PHARMA Labeling Approval
05/01/2024 TALICIA
NDA #213004		 SUPPL-14 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN REDHILL Labeling Approval
05/01/2024 SUGAMMADEX
ANDA #214230		 ORIG-1 SUGAMMADEX MANKIND PHARMA Tentative Approval
05/01/2024 VOQUEZNA TRIPLE PAK
NDA #215152		 SUPPL-7 AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE PHATHOM Labeling Approval
05/01/2024 VOQUEZNA DUAL PAK
NDA #215153		 SUPPL-7 AMOXICILLIN; VONOPRAZAN FUMARATE PHATHOM Labeling Approval
05/01/2024 MYHIBBIN
NDA #216482		 ORIG-1 MYCOPHENOLATE MOFETIL AZURITY Type 5 - New Formulation or New Manufacturer Approval
05/01/2024 AMPICILLIN TRIHYDRATE
ANDA #216554		 SUPPL-1 AMPICILLIN/AMPICILLIN TRIHYDRATE AUROBINDO PHARMA Labeling Approval
05/01/2024 MEMANTINE;DONEPEZIL HYDROCHLORIDES
ANDA #216901		 ORIG-1 MEMANTINE;DONEPEZIL HYDROCHLORIDES XIAMEN LP PHARM CO Tentative Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #217243		 SUPPL-4 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SHANDONG Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #217409		 SUPPL-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EUGIA PHARMA Labeling Approval
05/01/2024 PIPERACILLIN AND TAZOBACTAM
ANDA #217409		 SUPPL-1 PIPERACILLIN,TAZOBACTAM EUGIA PHARMA Labeling Approval
05/01/2024 OSELTAMIVIR PHOSPHATE
ANDA #218565		 ORIG-1 OSELTAMIVIR PHOSPHATE LAURUS Approval
05/02/2024 LANSOPRAZOLE
ANDA #201921		 SUPPL-8 LANSOPRAZOLE NATCO PHARMA LTD Labeling Approval
05/02/2024 ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #205703		 SUPPL-3 ESMOLOL HYDROCHLORIDE HQ SPCLT PHARMA Labeling Approval
05/02/2024 ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #205703		 SUPPL-3 ESMOLOL HYDROCHLORIDE HQ SPCLT PHARMA Labeling Approval
05/02/2024 FLUOXETINE HYDROCHLORIDE
ANDA #213265		 SUPPL-4 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
05/02/2024 OCTREOTIDE ACETATE
ANDA #217860		 ORIG-1 OCTREOTIDE ACETATE SHUANGCHENG Approval
05/02/2024 PREDNISOLONE
ANDA #218083		 ORIG-1 PREDNISOLONE ZHEJIANG XIANJU Approval
05/03/2024 KIONEX
ANDA #040028		 SUPPL-19 SODIUM POLYSTYRENE SULFONATE ANI PHARMS Manufacturing (CMC) Approval
05/03/2024 LANSOPRAZOLE
ANDA #202396		 SUPPL-3 LANSOPRAZOLE MYLAN Labeling Approval
05/03/2024 LANSOPRAZOLE
ANDA #202396		 SUPPL-4 LANSOPRAZOLE MYLAN Labeling Approval
05/03/2024 LANSOPRAZOLE
ANDA #202396		 SUPPL-6 LANSOPRAZOLE MYLAN Labeling Approval
05/03/2024 PLERIXAFOR
ANDA #206644		 ORIG-1 PLERIXAFOR GLAND PHARMA LTD Approval
05/03/2024 TRAVOPROST
ANDA #207040		 ORIG-1 TRAVOPROST LUPIN LTD Approval
05/03/2024 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #210380		 ORIG-1 CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Tentative Approval
05/03/2024 BORTEZOMIB
ANDA #212204		 ORIG-1 BORTEZOMIB HETERO LABS LTD VI Approval
05/03/2024 DEFERASIROX
ANDA #213146		 ORIG-1 DEFERASIROX MYLAN Approval
05/03/2024 ALBUTEROL SULFATE
ANDA #215571		 ORIG-1 ALBUTEROL SULFATE LEXENPHARM Approval
05/03/2024 ETICOVO
BLA #761066		 SUPPL-1 ETANERCEPT-YKRO SAMSUNG BIOEPIS CO LTD Approval
05/06/2024 NADOLOL
ANDA #074501		 SUPPL-13 NADOLOL SANDOZ Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091568		 SUPPL-11 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091568		 SUPPL-14 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091568		 SUPPL-18 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091568		 SUPPL-24 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569		 SUPPL-13 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569		 SUPPL-17 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #091569		 SUPPL-22 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
05/06/2024 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #202870		 SUPPL-22 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE ALEMBIC Labeling Approval
05/06/2024 KAITLIB FE
ANDA #203448		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Labeling Approval
05/06/2024 KAITLIB FE
ANDA #203448		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Manufacturing (CMC) Approval
05/06/2024 ROPINIROLE HYDROCHLORIDE
ANDA #204022		 SUPPL-3 ROPINIROLE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/06/2024 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #204626		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE IPCA LABS LTD Approval
05/06/2024 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207709		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
05/06/2024 EZETIMIBE
ANDA #210673		 SUPPL-8 EZETIMIBE SCIEGEN PHARMS INC Labeling Approval
05/06/2024 CLOBAZAM
ANDA #211711		 SUPPL-6 CLOBAZAM MICRO LABS Labeling Approval
05/06/2024 CERIANNA
NDA #212155		 SUPPL-21 FLUOROESTRADIOL F-18 GE HEALTHCARE Labeling Approval
05/06/2024 PERPHENAZINE
ANDA #212545		 ORIG-1 PERPHENAZINE MACLEODS PHARMS LTD Approval
05/06/2024 SCOPOLAMINE
ANDA #215329		 ORIG-1 SCOPOLAMINE RHODES PHARMS Approval
05/06/2024 EDARAVONE
ANDA #215508		 ORIG-1 EDARAVONE HIKMA Approval
05/06/2024 EDARAVONE
ANDA #215917		 ORIG-1 EDARAVONE DR REDDYS Approval
05/06/2024 EDARAVONE
ANDA #216199		 ORIG-1 EDARAVONE GLAND PHARMA LTD Approval
05/06/2024 EDARAVONE
ANDA #218354		 ORIG-1 EDARAVONE LONG GROVE PHARMS Approval
05/07/2024 WELLBUTRIN
NDA #018644		 SUPPL-61 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
05/07/2024 WELLBUTRIN SR
NDA #020358		 SUPPL-68 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
05/07/2024 WELLBUTRIN XL
NDA #021515		 SUPPL-46 BUPROPION HYDROCHLORIDE BAUSCH Labeling Approval
05/07/2024 APLENZIN
NDA #022108		 SUPPL-23 BUPROPION HYDROBROMIDE BAUSCH Labeling Approval
05/07/2024 FORFIVO XL
NDA #022497		 SUPPL-15 BUPROPION HYDROCHLORIDE TWI PHARMS Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #075310		 SUPPL-28 BUPROPION HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-40 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #075584		 SUPPL-60 BUPROPION HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #075914		 SUPPL-32 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #076143		 SUPPL-33 BUPROPION HYDROCHLORIDE APOTEX INC Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #076834		 SUPPL-16 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-21 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-36 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
05/07/2024 CORTISONE ACETATE
ANDA #080776		 SUPPL-44 CORTISONE ACETATE HIKMA INTL PHARMS Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #090941		 SUPPL-16 BUPROPION HYDROCHLORIDE RISING Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #091520		 SUPPL-9 BUPROPION HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
05/07/2024 CONTRAVE
NDA #200063		 SUPPL-22 BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE NALPROPION Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #202775		 SUPPL-15 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #203013		 SUPPL-15 BUPROPION HYDROCHLORIDE ALEMBIC Labeling Approval
05/07/2024 REXULTI
NDA #205422		 SUPPL-11 BREXPIPRAZOLE OTSUKA Efficacy Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #206122		 SUPPL-16 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #206975		 SUPPL-30 BUPROPION HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #207389		 SUPPL-8 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #207403		 SUPPL-4 BUPROPION HYDROCHLORIDE MICRO LABS Labeling Approval
05/07/2024 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207549		 SUPPL-12 METHYLPREDNISOLONE SODIUM SUCCINATE AMNEAL Labeling Approval
05/07/2024 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207549		 SUPPL-16 METHYLPREDNISOLONE SODIUM SUCCINATE AMNEAL Labeling Approval
05/07/2024 METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207549		 SUPPL-17 METHYLPREDNISOLONE SODIUM SUCCINATE AMNEAL Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #208606		 SUPPL-3 BUPROPION HYDROCHLORIDE CADILA PHARMS LTD Labeling Approval
05/07/2024 METHYLPREDNISOLONE ACETATE
ANDA #210043		 SUPPL-32 METHYLPREDNISOLONE ACETATE AMNEAL Labeling Approval
05/07/2024 METHYLPREDNISOLONE ACETATE
ANDA #210043		 SUPPL-33 METHYLPREDNISOLONE ACETATE AMNEAL Labeling Approval
05/07/2024 AUVELITY
NDA #215430		 SUPPL-8 BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE AXSOME Labeling Approval
05/07/2024 BUPROPION HYDROCHLORIDE
ANDA #216766		 SUPPL-2 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Labeling Approval
05/07/2024 DICYCLOMINE HYDROCHLORIDE
ANDA #217566		 ORIG-1 DICYCLOMINE HYDROCHLORIDE ANNORA PHARMA Approval
05/08/2024 EXELON
NDA #022083		 SUPPL-28 RIVASTIGMINE SANDOZ Labeling Approval
05/08/2024 MONODOX
NDA #050641		 SUPPL-33 DOXYCYCLINE CHARTWELL RX Labeling Approval
05/08/2024 DOCETAXEL
ANDA #208137		 SUPPL-6 DOCETAXEL MYLAN LABS LTD Labeling Approval
05/08/2024 LINAGLIPTIN
ANDA #213602		 ORIG-1 LINAGLIPTIN MACLEODS PHARMS LTD Tentative Approval
05/08/2024 VASOPRESSIN
ANDA #213988		 ORIG-1 VASOPRESSIN DR REDDYS Approval
05/08/2024 DAPSONE
ANDA #214019		 ORIG-1 DAPSONE ZYDUS Approval
05/08/2024 AZELASTINE HYDROCHLORIDE
ANDA #216801		 ORIG-1 AZELASTINE HYDROCHLORIDE PADAGIS ISRAEL Approval
05/09/2024 DOXORUBICIN HYDROCHLORIDE
NDA #050629		 SUPPL-33 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
05/09/2024 ANAGRELIDE HYDROCHLORIDE
ANDA #076683		 SUPPL-11 ANAGRELIDE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/09/2024 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 SUPPL-10 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
05/09/2024 BETASERON
BLA #103471		 SUPPL-5203 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
05/09/2024 DOXAZOSIN MESYLATE
ANDA #205210		 SUPPL-7 DOXAZOSIN MESYLATE HERITAGE PHARMA Labeling Approval
05/09/2024 IMBRUVICA
NDA #205552		 SUPPL-42 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
05/09/2024 NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
ANDA #207372		 SUPPL-16 NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE AMNEAL PHARMS Labeling Approval
05/09/2024 IMBRUVICA
NDA #210563		 SUPPL-18 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
05/09/2024 SEVELAMER CARBONATE
ANDA #211915		 ORIG-1 SEVELAMER CARBONATE STRIDES PHARMA Approval
05/09/2024 EPTIFIBATIDE
ANDA #213599		 ORIG-1 EPTIFIBATIDE HONG KONG Approval
05/09/2024 POTASSIUM CHLORIDE
ANDA #216269		 ORIG-1 POTASSIUM CHLORIDE MACLEODS PHARMS LTD Approval
05/09/2024 DEXAMETHASONE
ANDA #216284		 ORIG-1 DEXAMETHASONE ZYDUS PHARMS Approval
05/09/2024 IMBRUVICA
NDA #217003		 SUPPL-3 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
05/09/2024 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #217784		 ORIG-1 OMEPRAZOLE; SODIUM BICARBONATE DR REDDYS Approval
05/09/2024 PROCHLORPERAZINE MALEATE
ANDA #218515		 ORIG-1 PROCHLORPERAZINE MALEATE AJANTA PHARMA LTD Approval
05/10/2024 MAVENCLAD
NDA #022561		 SUPPL-11 CLADRIBINE EMD SERONO INC Labeling Approval
05/10/2024 PREDNISONE
ANDA #040538		 SUPPL-6 PREDNISONE HIKMA PHARMS Labeling Approval
05/10/2024 MELOXICAM
ANDA #077927		 SUPPL-44 MELOXICAM UNICHEM Labeling Approval
05/10/2024 DEXAMETHASONE
ANDA #085456		 SUPPL-22 DEXAMETHASONE CHARTWELL RX Labeling Approval
05/10/2024 EFAVIRENZ
ANDA #091579		 ORIG-1 EFAVIRENZ MACLEODS PHARMS LTD Approval
05/10/2024 DECITABINE
ANDA #215355		 ORIG-1 DECITABINE HETERO LABS LTD VI Approval
05/10/2024 MIDOSTAURIN
ANDA #216015		 ORIG-1 MIDOSTAURIN LUPIN Approval
05/10/2024 CALCIUM GLUCONATE
ANDA #216611		 ORIG-1 CALCIUM GLUCONATE AMNEAL Approval
05/10/2024 FLUTICASONE PROPIONATE
ANDA #217088		 ORIG-1 FLUTICASONE PROPIONATE AUROBINDO PHARMA LTD Approval
05/10/2024 PHENYLEPHRINE HYDROCHLORIDE
ANDA #218110		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE ASPIRO Approval
05/10/2024 OSELTAMIVIR PHOSPHATE
ANDA #218131		 ORIG-1 OSELTAMIVIR PHOSPHATE AUROBINDO PHARMA LTD Approval
05/10/2024 CISPLATIN
ANDA #218868		 ORIG-1 CISPLATIN QILU Approval
05/13/2024 NAPROSYN
NDA #017581		 SUPPL-116 NAPROXEN ATNAHS PHARMA US Labeling Approval
05/13/2024 ANAPROX
NDA #018164		 SUPPL-66 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
05/13/2024 ANAPROX DS
NDA #018164		 SUPPL-66 NAPROXEN SODIUM ATNAHS PHARMA US Labeling Approval
05/13/2024 EC-NAPROSYN
NDA #020067		 SUPPL-25 NAPROXEN ATNAHS PHARMA US Labeling Approval
05/13/2024 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-50 FOLLITROPIN ALFA/BETA EMD SERONO Approval
05/13/2024 GONAL-F RFF REDI-JECT
BLA #021684		 SUPPL-51 FOLLITROPIN ALFA/BETA EMD SERONO Approval
05/13/2024 MEPERIDINE HYDROCHLORIDE
ANDA #040446		 SUPPL-15 MEPERIDINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
05/13/2024 DOXYCYCLINE
ANDA #065471		 SUPPL-2 DOXYCYCLINE SUN PHARM INDUSTRIES Labeling Approval
05/13/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091601		 SUPPL-14 METHYLPHENIDATE HYDROCHLORIDE TRIS PHARMA INC Labeling Approval
05/13/2024 MYCOPHENOLATE MOFETIL HYDROCHLORIDE
ANDA #203575		 SUPPL-8 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-4 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-6 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-8 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-14 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-17 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-19 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 ESOMEPRAZOLE MAGNESIUM
ANDA #205606		 SUPPL-21 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA LTD Labeling Approval
05/13/2024 DICLOFENAC SODIUM
ANDA #210893		 SUPPL-2 DICLOFENAC SODIUM PADAGIS ISRAEL Labeling Approval
05/13/2024 DICLOFENAC SODIUM
ANDA #210893		 SUPPL-5 DICLOFENAC SODIUM PADAGIS ISRAEL Labeling Approval
05/13/2024 TIZANIDINE HYDROCHLORIDE
ANDA #213365		 ORIG-1 TIZANIDINE HYDROCHLORIDE APPCO Approval
05/13/2024 NOREPINEPHRINE BITARTRATE
ANDA #218758		 ORIG-1 NOREPINEPHRINE BITARTRATE DDREG PHARMA Approval
05/14/2024 TRIGLIDE
NDA #021350		 SUPPL-24 FENOFIBRATE SKYEPHARMA AG Labeling Approval
05/14/2024 LANSOPRAZOLE
ANDA #202194		 SUPPL-12 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
05/14/2024 LANSOPRAZOLE
ANDA #202194		 SUPPL-13 LANSOPRAZOLE DR REDDYS LABS LTD Labeling Approval
05/14/2024 XELJANZ
NDA #203214		 SUPPL-34 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
05/14/2024 DIFLUPREDNATE
ANDA #207284		 ORIG-1 DIFLUPREDNATE EPIC PHARMA LLC Approval
05/14/2024 FINGOLIMOD HYDROCHLORIDE
ANDA #207939		 SUPPL-10 FINGOLIMOD HYDROCHLORIDE HEC PHARM CO LTD Labeling Approval
05/14/2024 FINGOLIMOD HYDROCHLORIDE
ANDA #207939		 SUPPL-12 FINGOLIMOD HYDROCHLORIDE HEC PHARM CO LTD Labeling Approval
05/14/2024 XELJANZ XR
NDA #208246		 SUPPL-21 TOFACITINIB CITRATE PFIZER Labeling Approval
05/14/2024 XELJANZ
NDA #213082		 SUPPL-6 TOFACITINIB CITRATE PFIZER Labeling Approval
05/14/2024 NIMODIPINE
ANDA #216256		 ORIG-1 NIMODIPINE AMNEAL PHARMS LLC Tentative Approval
05/14/2024 LIKMEZ
NDA #216755		 SUPPL-1 METRONIDAZOLE SAPTALIS PHARMS Labeling Approval
05/14/2024 AURLUMYN
NDA #217933		 SUPPL-1 ILOPROST EICOS SCI Labeling Approval
05/14/2024 LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA #218017		 ORIG-1 LORATADINE; PSEUDOEPHEDRINE SULFATE BIONPHARMA Approval
05/14/2024 ACETAZOLAMIDE
ANDA #218023		 ORIG-1 ACETAZOLAMIDE EPIC PHARMA LLC Approval
05/15/2024 SOTALOL HYDROCHLORIDE
ANDA #075429		 SUPPL-30 SOTALOL HYDROCHLORIDE TEVA Labeling Approval
05/15/2024 KETOROLAC TROMETHAMINE
ANDA #078721		 SUPPL-4 KETOROLAC TROMETHAMINE SANDOZ Labeling Approval
05/15/2024 TEMOZOLOMIDE
ANDA #201528		 SUPPL-8 TEMOZOLOMIDE ACCORD HLTHCARE Labeling Approval
05/15/2024 TEMOZOLOMIDE
ANDA #203490		 SUPPL-12 TEMOZOLOMIDE ANI PHARMS Labeling Approval
05/15/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207515		 SUPPL-12 METHYLPHENIDATE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
05/15/2024 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207515		 SUPPL-17 METHYLPHENIDATE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
05/15/2024 CLOBAZAM
ANDA #209853		 SUPPL-3 CLOBAZAM APOTEX Labeling Approval
05/15/2024 CLOBAZAM
ANDA #210545		 SUPPL-5 CLOBAZAM LUPIN LTD Labeling Approval
05/15/2024 NADOLOL
ANDA #210955		 SUPPL-5 NADOLOL BEXIMCO PHARMS USA Labeling Approval
05/15/2024 ACETAZOLAMIDE
ANDA #214282		 SUPPL-18 ACETAZOLAMIDE MANKIND PHARMA Manufacturing (CMC) Approval
05/15/2024 CLOBAZAM
ANDA #214404		 SUPPL-2 CLOBAZAM AUROBINDO PHARMA LTD Labeling Approval
05/15/2024 LACOSAMIDE
ANDA #215154		 ORIG-1 LACOSAMIDE CHARTWELL RX Approval
05/16/2024 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-13 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
05/16/2024 BENLYSTA
BLA #125370		 SUPPL-81 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
05/16/2024 TEMOZOLOMIDE
ANDA #204159		 SUPPL-3 TEMOZOLOMIDE APOTEX Labeling Approval
05/16/2024 MITIGARE
NDA #204820		 SUPPL-6 COLCHICINE HIKMA INTL PHARMS Labeling Approval
05/16/2024 AZACITIDINE
ANDA #212580		 ORIG-1 AZACITIDINE MSN LABS PVT LTD Approval
05/16/2024 EOHILIA
NDA #213976		 SUPPL-1 BUDESONIDE TAKEDA PHARMS USA Labeling Approval
05/16/2024 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
ANDA #214987		 ORIG-1 BRIMONIDINE TARTRATE; TIMOLOL MALEATE GLENMARK PHARMS LTD Approval
05/16/2024 CYCLOSPORINE
ANDA #216046		 SUPPL-7 CYCLOSPORINE STRIDES PHARMA Labeling Approval
05/16/2024 METHOTREXATE SODIUM
ANDA #216453		 ORIG-1 METHOTREXATE SODIUM ELITE LABS INC Approval
05/16/2024 BENLYSTA
BLA #761043		 SUPPL-27 BELIMUMAB GLAXOSMITHKLINE LLC Approval
05/16/2024 REBLOZYL
BLA #761136		 SUPPL-10 LUSPATERCEPT-AAMT CELGENE CORP Approval
05/16/2024 IMDELLTRA
BLA #761344		 ORIG-1 TARLATAMAB-DLLE AMGEN INC Approval
05/17/2024 MUSE
NDA #020700		 SUPPL-32 ALPROSTADIL MYLAN SPECIALITY LP Labeling Approval
05/17/2024 CADUET
NDA #021540		 SUPPL-49 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
05/17/2024 ANASTROZOLE
ANDA #078058		 SUPPL-14 ANASTROZOLE TEVA PHARMS Labeling Approval
05/17/2024 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202713		 SUPPL-2 AMLODIPINE BESYLATE; VALSARTAN ALEMBIC Labeling Approval
05/17/2024 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202713		 SUPPL-12 AMLODIPINE BESYLATE; VALSARTAN ALEMBIC Labeling Approval
05/17/2024 AMLODIPINE BESYLATE AND VALSARTAN
ANDA #202713		 SUPPL-20 AMLODIPINE BESYLATE; VALSARTAN ALEMBIC Labeling Approval
05/17/2024 FROVATRIPTAN SUCCINATE
ANDA #211292		 SUPPL-4 FROVATRIPTAN SUCCINATE AMNEAL PHARMS CO Labeling Approval
05/17/2024 EPRONTIA
NDA #214679		 SUPPL-7 TOPIRAMATE AZURITY Labeling Approval
05/20/2024 YESAFILI
BLA #761274		 ORIG-1 AFLIBERCEPT-JBVF BIOCON BIOLOGICS INC Approval
05/20/2024 OPUVIZ
BLA #761350		 ORIG-1 AFLIBERCEPT-YSZY SAMSUNG BIOEPIS CO LTD Approval
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