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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) 220073 001 ELIQUIS SPRINKLEP APIXABAN FOR SUSPENSION;ORAL 0.15MG BRISTOL 2025-04-17 Yes RX
(NDA) 220020 001 YEZTUGO LENACAPAVIR SODIUM TABLET;ORAL EQ 300MG BASE GILEAD SCIENCES INC 2025-06-18 Yes RX
(NDA) 220018 001 YEZTUGO LENACAPAVIR SODIUM SOLUTION;SUBCUTANEOUS EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) GILEAD SCIENCES INC 2025-06-18 Yes RX
(NDA) 219920 001 AVGEMSI GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) AVYXA HOLDINGS 2025-06-27 Yes RX
(NDA) 219920 002 AVGEMSI GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) AVYXA HOLDINGS 2025-06-27 Yes RX
(NDA) 219920 003 AVGEMSI GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) AVYXA HOLDINGS 2025-06-27 Yes RX
(ANDA) 219883 001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) ANTHEA PHARMA 2025-03-21 No RX AP
(ANDA) 219883 002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) ANTHEA PHARMA 2025-03-21 No RX AP
(ANDA) 219883 003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) ANTHEA PHARMA 2025-03-21 No RX AP
(NDA) 219847 001 ARYNTAP LISDEXAMFETAMINE DIMESYLATE SOLUTION;ORAL 10MG/ML AZURITY 2025-06-16 Yes RX
(ANDA) 219777 001 MAGNESIUM SULFATE MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 1GM/2ML (500MG/ML) ASPIRO 2025-05-28 No RX AP
(ANDA) 219777 002 MAGNESIUM SULFATE MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 5GM/10ML (500MG/ML) ASPIRO 2025-05-28 No RX AP
(ANDA) 219777 003 MAGNESIUM SULFATE MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 10GM/20ML (500MG/ML) ASPIRO 2025-05-28 No RX AP
(ANDA) 219777 004 MAGNESIUM SULFATE MAGNESIUM SULFATE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 25GM/50ML (500MG/ML) ASPIRO 2025-05-28 No RX AP
(ANDA) 219775 001 ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL GLAND 2025-06-17 No RX AP
(ANDA) 219767 001 TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.4MG GRAVITI PHARMS 2025-05-01 No RX AB
(NDA) 219713 001 IBTROZIP TALETRECTINIB ADIPATE CAPSULE;ORAL EQ 200MG BASE NUVATION 2025-06-11 Yes RX
(ANDA) 219701 001 SODIUM BICARBONATE SODIUM BICARBONATE INJECTABLE;INJECTION 1MEQ/ML ANTHEA PHARMA 2025-06-26 No RX AP
(ANDA) 219699 001 LACOSAMIDE LACOSAMIDE SOLUTION;ORAL 10MG/ML AJENAT PHARMS 2025-06-26 No RX AA
(ANDA) 219689 001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL EQ 1MG BASE RUBICON 2025-04-15 No RX AB