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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) 212862 001 PRETOMANID PRETOMANID TABLET;ORAL 200MG TB ALLIANCE 2019-08-14 Yes RX
(NDA) 212819 001 RECARBRIOP CILASTATIN SODIUM; IMIPENEM; RELEBACTAM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL MSD MERCK CO 2019-07-16 Yes RX
(ANDA) 212780 001 AMINOCAPROIC ACID AMINOCAPROIC ACID SYRUP;ORAL 1.25GM/5ML AMNEAL PHARMS LLC 2019-08-23 No RX AA
(NDA) 212725 001 ROZLYTREK ENTRECTINIB CAPSULE;ORAL 100MG GENENTECH INC 2019-08-15 Yes RX
(NDA) 212725 002 ROZLYTREK ENTRECTINIB CAPSULE;ORAL 200MG GENENTECH INC 2019-08-15 Yes RX
(ANDA) 212714 001 CLOBAZAM CLOBAZAM TABLET;ORAL 10MG ALKEM LABS LTD 2019-09-06 No RX AB
(ANDA) 212714 002 CLOBAZAM CLOBAZAM TABLET;ORAL 20MG ALKEM LABS LTD 2019-09-06 No RX AB
(ANDA) 212676 001 TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML APOLLO PHARMS INC 2019-07-17 No RX AP
(ANDA) 212667 001 DAPTOMYCIN DAPTOMYCIN POWDER;IV (INFUSION) 350MG/VIAL ACCORD HLTHCARE 2019-07-12 No RX AP
(ANDA) 212639 001 DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 2% BASE ALEMBIC PHARMS LTD 2019-08-09 No RX AT
(ANDA) 212631 001 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 2.5MG ALKEM LABS LTD 2019-07-19 No RX AB
(ANDA) 212631 002 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 5MG ALKEM LABS LTD 2019-07-19 No RX AB
(ANDA) 212631 003 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET;ORAL 10MG ALKEM LABS LTD 2019-07-19 No RX AB
(ANDA) 212619 001 AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG GRANULES PHARMS 2019-08-05 No RX AA
(ANDA) 212619 002 AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 10MG GRANULES PHARMS 2019-08-05 No RX AA
(ANDA) 212598 001 FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 45MG FENOFIBRIC ACID AUROBINDO PHARMA LTD 2019-07-25 No RX AB
(ANDA) 212598 002 FENOFIBRIC ACID CHOLINE FENOFIBRATE CAPSULE, DELAYED RELEASE;ORAL EQ 135MG FENOFIBRIC ACID AUROBINDO PHARMA LTD 2019-07-25 No RX AB
(NDA) 212595 001 RIOMET ERP METFORMIN HYDROCHLORIDE FOR SUSPENSION, EXTENDED RELEASE;ORAL 500MG/5ML SUN PHARM 2019-08-29 Yes RX
(ANDA) 212557 001 NYSTATIN NYSTATIN CREAM;TOPICAL 100,000 UNITS/GM TORRENT 2019-07-24 No RX AT
(ANDA) 212543 001 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG RUBICON 2019-08-19 No RX AB