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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYHB2500192 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Supplementary Application 2025-04-03 Renaissance Lakewood LLC;Janssen Cilag Manufacturing LLC;Janssen-Cilag International NV view
JYHB2500175 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Supplementary Application 2025-03-21 Renaissance Lakewood LLC;Janssen-Cilag International NV view
JYHB2400519 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Supplementary Application 2024-10-09 Renaissance Lakewood LLC;Janssen-Cilag International NV view
JYHB2400118 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Supplementary Application 2024-03-09 Renaissance Lakewood LLC;Janssen-Cilag International NV view
JYHB2300611 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Supplementary Application 2023-10-26 Renaissance Lakewood LLC;Janssen-Cilag International NV view
JXHS2200017 盐酸艾司氯胺酮鼻喷雾剂 esketamine hydrochloride Spray Chemical Drugs(5.1) Import Drug Application 2022-01-27 Xian Janssen Pharmaceutical Ltd;Renaissance Lakewood LLC;Janssen-Cilag International NV view