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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) 214689 001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE UNICHEM 2021-03-03 No RX AB
(ANDA) 214689 002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE UNICHEM 2021-03-03 No RX AB
(ANDA) 214686 001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 8MEQ GRANULES 2021-02-16 No RX AB
(ANDA) 214686 002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 10MEQ GRANULES 2021-02-16 No RX AB
(ANDA) 214684 001 LORATADINE LORATADINE TABLET;ORAL 10MG UNIQUE PHARM 2021-01-07 No OTC
(ANDA) 214674 001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG NOVITIUM PHARMA 2021-03-01 No RX AB