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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(NDA) 218550 001 ROZLYTREK ENTRECTINIB PELLETS;ORAL 50MG/PACKET GENENTECH INC 2023-10-20 Yes RX
(ANDA) 218149 001 METHIMAZOLE METHIMAZOLE TABLET;ORAL 5MG BIONPHARMA 2023-09-25 No RX AB
(ANDA) 218149 002 METHIMAZOLE METHIMAZOLE TABLET;ORAL 10MG BIONPHARMA 2023-09-25 No RX AB
(ANDA) 218122 001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE CAPSULE;ORAL 2MG AUROBINDO PHARMA LTD 2023-09-05 No RX AB
(ANDA) 218055 001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG AUROBINDO PHARMA LTD 2023-08-18 No RX AB
(ANDA) 218055 002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG AUROBINDO PHARMA LTD 2023-08-18 No RX AB
(ANDA) 218055 003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG AUROBINDO PHARMA LTD 2023-08-18 No RX AB
(ANDA) 218055 004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG AUROBINDO PHARMA LTD 2023-08-18 No RX AB
(ANDA) 218036 001 LITHIUM CITRATE LITHIUM CITRATE SYRUP;ORAL EQ 300MG CARBONATE/5ML RUBICON 2023-08-14 No RX AA
(ANDA) 218024 001 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE NATCO PHARMA 2023-10-24 No RX AB
(ANDA) 218024 002 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE NATCO PHARMA 2023-10-24 No RX AB
(ANDA) 218024 003 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE NATCO PHARMA 2023-10-24 No RX AB
(ANDA) 218024 004 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE NATCO PHARMA 2023-10-24 No RX AB
(ANDA) 218015 001 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;50MG GRANULES 2023-09-29 No RX AB
(ANDA) 218015 002 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 12.5MG;100MG GRANULES 2023-09-29 No RX AB
(ANDA) 218015 003 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TABLET;ORAL 25MG;100MG GRANULES 2023-09-29 No RX AB
(ANDA) 218012 001 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 12.5MG BASE NOVUGEN 2023-08-21 No RX AB
(ANDA) 218012 002 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 25MG BASE NOVUGEN 2023-08-21 No RX AB
(ANDA) 218012 003 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 37.5MG BASE NOVUGEN 2023-08-21 No RX AB
(ANDA) 218012 004 SUNITINIB MALATE SUNITINIB MALATE CAPSULE;ORAL EQ 50MG BASE NOVUGEN 2023-08-21 No RX AB