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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) 218550 001 ROZLYTREK ENTRECTINIB PELLETS;ORAL 50MG/PACKET GENENTECH INC 2023-10-20 Yes RX
(ANDA) 218467 001 SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS 100MG/5ML (20MG/ML) DR REDDYS 2024-01-17 No RX AP
(ANDA) 218371 001 HALOPERIDOL HALOPERIDOL LACTATE CONCENTRATE;ORAL EQ 2MG BASE/ML RUBICON 2024-01-31 No RX AA
(ANDA) 218366 001 PRIMIDONE PRIMIDONE TABLET;ORAL 50MG CARNEGIE 2024-01-23 No RX AB
(ANDA) 218366 002 PRIMIDONE PRIMIDONE TABLET;ORAL 250MG CARNEGIE 2024-01-23 No RX AB
(ANDA) 218306 001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 10MG MSN 2024-02-02 No RX AB
(ANDA) 218306 002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 20MG MSN 2024-02-02 No RX AB
(ANDA) 218306 003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 30MG MSN 2024-02-02 No RX AB
(ANDA) 218306 004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 40MG MSN 2024-02-02 No RX AB
(ANDA) 218306 005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 50MG MSN 2024-02-02 No RX AB
(ANDA) 218306 006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE;ORAL 60MG MSN 2024-02-02 No RX AB
(ANDA) 218290 001 CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE CAPSULE;ORAL 30MG BIONPHARMA 2023-11-08 No RX AB
(NDA) 218276 001 FABHALTAP IPTACOPAN HYDROCHLORIDE CAPSULE;ORAL EQ 200MG BASE NOVARTIS 2023-12-05 Yes RX
(NDA) 218213 001 AUGTYROP REPOTRECTINIB CAPSULE;ORAL 40MG BRISTOL 2023-11-15 Yes RX
(NDA) 218197 001 TRUQAPP CAPIVASERTIB TABLET;ORAL 160MG ASTRAZENECA 2023-11-16 Yes RX
(NDA) 218197 002 TRUQAPP CAPIVASERTIB TABLET;ORAL 200MG ASTRAZENECA 2023-11-16 Yes RX
(ANDA) 218194 001 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 10MG AUROBINDO PHARMA 2024-01-29 No RX AB2
(ANDA) 218194 002 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 20MG AUROBINDO PHARMA 2024-01-29 No RX AB2
(ANDA) 218194 003 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 25MG AUROBINDO PHARMA 2024-01-29 No RX AB2
(ANDA) 218194 004 ISOTRETINOIN ISOTRETINOIN CAPSULE;ORAL 30MG AUROBINDO PHARMA 2024-01-29 No RX AB2