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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) 215028 001 ETOMIDATE ETOMIDATE INJECTABLE;INJECTION 2MG/ML CAPLIN 2020-12-18 No RX AP
(ANDA) 214879 001 SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INJECTABLE;INJECTION 20MG/ML MICRO LABS 2020-11-24 No RX AP
(ANDA) 214839 001 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML BE PHARMS 2020-12-29 No RX AP
(ANDA) 214804 001 HEPARIN SODIUM HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML BE PHARMS 2020-12-29 No RX AP
(ANDA) 214803 001 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.005MG BASE ZYDUS 2021-01-22 No RX AB
(ANDA) 214803 002 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.025MG BASE ZYDUS 2021-01-22 No RX AB
(ANDA) 214803 003 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.05MG BASE ZYDUS 2021-01-22 No RX AB
(NDA) 214787 001 VEKLURYP REMDESIVIR POWDER;INTRAVENOUS 100MG/VIAL GILEAD SCIENCES INC 2020-10-22 Yes RX
(NDA) 214787 002 VEKLURYP REMDESIVIR SOLUTION;INTRAVENOUS 100MG/20ML (5MG/ML) GILEAD SCIENCES INC 2020-10-22 Yes RX
(ANDA) 214785 001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 0.4MG/ML BAXTER HLTHCARE CORP 2021-01-29 No RX AP
(ANDA) 214766 001 FUROSEMIDE FUROSEMIDE INJECTABLE;INJECTION 10MG/ML ATHENEX INC 2021-01-27 No RX AP
(ANDA) 214734 001 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 2.5MG ALEMBIC PHARMS LTD 2021-01-21 No RX AB
(ANDA) 214734 002 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 5MG ALEMBIC PHARMS LTD 2021-01-21 No RX AB
(ANDA) 214734 003 MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET;ORAL 10MG ALEMBIC PHARMS LTD 2021-01-21 No RX AB
(ANDA) 214684 001 LORATADINE LORATADINE TABLET;ORAL 10MG UNIQUE PHARM 2021-01-07 No OTC
(NDA) 214652 001 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 0.4MG/ML (0.4MG/ML) ACCORD HLTHCARE 2020-09-29 Yes RX
(NDA) 214652 002 ATROPINE SULFATE ATROPINE SULFATE SOLUTION;INTRAVENOUS 1MG/ML (1MG/ML) ACCORD HLTHCARE 2020-09-29 Yes RX
(NDA) 214621 001 ORGOVYXP RELUGOLIX TABLET;ORAL 120MG MYOVANT SCIENCES 2020-12-18 Yes RX
(ANDA) 214603 001 GEMFIBROZIL GEMFIBROZIL TABLET;ORAL 600MG ASCENT PHARMS INC 2021-01-13 No RX AB
(ANDA) 214574 001 AMPHETAMINE SULFATE AMPHETAMINE SULFATE TABLET;ORAL 5MG SUN PHARM INDS INC 2021-01-27 No RX AA