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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 07, 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 PAR STERILE PRODUCTS Labeling Approval
05/01/2024 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #203972		 SUPPL-15 DEXMEDETOMIDINE HYDROCHLORIDE PAR STERILE PRODUCTS 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 PAR STERILE PRODUCTS 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 PHARMACEUTICALS INC 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 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 ROPINIROLE HYDROCHLORIDE
ANDA #204022		 SUPPL-3 ROPINIROLE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/06/2024 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
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