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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(ANDA) 219050 001 EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) CAPLIN 2024-07-18 No RX AP
(NDA) 219016 001 EDURANT PEDP RILPIVIRINE HYDROCHLORIDE TABLET, FOR SUSPENSION;ORAL EQ 2.5MG BASE JANSSEN PRODS 2024-03-15 Yes RX
(ANDA) 219002 001 TRAMETINIB DIMETHYL SULFOXIDE TRAMETINIB DIMETHYL SULFOXIDE TABLET;ORAL EQ 0.5MG NOVUGEN 2024-08-06 No RX AB
(ANDA) 219002 002 TRAMETINIB DIMETHYL SULFOXIDE TRAMETINIB DIMETHYL SULFOXIDE TABLET;ORAL EQ 2MG NOVUGEN 2024-08-06 No RX AB
(ANDA) 218991 001 VALSARTAN VALSARTAN TABLET;ORAL 40MG ZYDUS LIFESCIENCES 2024-07-22 No RX AB
(ANDA) 218991 002 VALSARTAN VALSARTAN TABLET;ORAL 80MG ZYDUS LIFESCIENCES 2024-07-22 No RX AB
(ANDA) 218991 003 VALSARTAN VALSARTAN TABLET;ORAL 160MG ZYDUS LIFESCIENCES 2024-07-22 No RX AB
(ANDA) 218991 004 VALSARTAN VALSARTAN TABLET;ORAL 320MG ZYDUS LIFESCIENCES 2024-07-22 No RX AB
(ANDA) 218920 001 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE GRAVITI PHARMS 2024-08-07 No RX AB
(ANDA) 218920 002 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET;ORAL EQ 4MG BASE GRAVITI PHARMS 2024-08-07 No RX AB
(ANDA) 218868 001 CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML QILU 2024-05-10 No RX AP
(NDA) 218860 001 IQIRVOP ELAFIBRANOR TABLET;ORAL 80MG IPSEN 2024-06-10 Yes RX
(ANDA) 218789 001 HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(ANDA) 218789 002 HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(ANDA) 218789 003 HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(ANDA) 218789 004 HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(ANDA) 218789 005 HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(ANDA) 218789 006 HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG AUROBINDO PHARMA LTD 2024-04-19 No RX AB
(NDA) 218771 001 TERIPARATIDE TERIPARATIDE SOLUTION;SUBCUTANEOUS 0.6MG/2.4ML (0.25MG/ML) ALMAJECT 2024-06-04 Yes RX
(ANDA) 218758 001 NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML RISING 2024-05-13 No RX AP