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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) 218289 001 BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED;TOPICAL EQ 0.05% BASE AUROBINDO PHARMA LTD 2024-04-10 No RX AB
(ANDA) 218202 001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG SKG PHARMA 2024-04-10 No RX AB
(ANDA) 218202 002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG SKG PHARMA 2024-04-10 No RX AB
(ANDA) 217134 003 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 61% HAINAN POLY 2024-04-09 No RX AP
(ANDA) 217134 004 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 76% HAINAN POLY 2024-04-09 No RX AP
(ANDA) 218163 001 RASAGILINE MESYLATE RASAGILINE MESYLATE TABLET;ORAL EQ 0.5MG BASE SKG PHARMA 2024-04-09 No RX AB
(ANDA) 217134 002 IOPAMIDOL IOPAMIDOL INJECTABLE;INJECTION 51% HAINAN POLY 2024-04-09 No RX AP
(ANDA) 218163 002 RASAGILINE MESYLATE RASAGILINE MESYLATE TABLET;ORAL EQ 1MG BASE SKG PHARMA 2024-04-09 No RX AB
(ANDA) 090857 001 CEFPROZIL CEFPROZIL TABLET;ORAL 250MG ALKEM LABS LTD 2024-04-09 No RX AB
(ANDA) 090857 002 CEFPROZIL CEFPROZIL TABLET;ORAL 500MG ALKEM LABS LTD 2024-04-09 No RX AB
(ANDA) 218034 001 DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL 40MG DR REDDYS 2024-04-08 No RX AB
(ANDA) 217965 002 GABAPENTIN GABAPENTIN TABLET;ORAL 800MG LAURUS 2024-04-08 No RX AB1
(ANDA) 217263 001 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML AM REGENT 2024-04-08 No RX AP
(ANDA) 217965 001 GABAPENTIN GABAPENTIN TABLET;ORAL 600MG LAURUS 2024-04-08 No RX AB1
(ANDA) 216631 001 DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL 40MG LUPIN 2024-04-08 No RX AB
(ANDA) 213506 001 IBUPROFEN IBUPROFEN SUSPENSION/DROPS;ORAL 40MG/ML AUROBINDO PHARMA LTD 2024-04-08 No OTC
(ANDA) 218002 001 TAFLUPROST TAFLUPROST SOLUTION/DROPS;OPHTHALMIC 0.0015% INGENUS PHARMS LLC 2024-04-05 No RX AT
(ANDA) 218047 001 ERIBULIN MESYLATE ERIBULIN MESYLATE SOLUTION;INTRAVENOUS 1MG/2ML (0.5MG/ML) GLAND PHARMA LTD 2024-04-05 No RX AP
(ANDA) 216064 001 VALBENAZINE TOSYLATE VALBENAZINE TOSYLATE CAPSULE;ORAL EQ 40MG BASE LUPIN LTD 2024-04-05 No RX AB
(ANDA) 211269 002 MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL FRESENIUS KABI USA 2024-04-05 No RX AP