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| 申请类型 | 申请号 | 药品名称 | 活性成分 | 活性成分中文 | 执行时间 | 持有公司 | 说明书 |
|---|---|---|---|---|---|---|---|
| NDA | 210589 | OMEGAVEN | FISH OIL TRIGLYCERIDES | 查看 | 2025-07-28 | FRESENIUS KABI USA | 查看 |
| NDA | 207648 | SMOFLIPID 20% | FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS KABI USA | 查看 |
| NDA | 200656 | PERIKABIVEN IN PLASTIC CONTAINER | AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS KABI USA | 查看 |
| NDA | 017643 | INTRALIPID 10% | SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS | 查看 |
| NDA | 018449 | INTRALIPID 20% | SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS | 查看 |
| NDA | 019942 | INTRALIPID 30% | SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS | 查看 |
| NDA | 020248 | INTRALIPID 20% | SOYBEAN OIL | 查看 | 2025-07-28 | FRESENIUS | 查看 |
| NDA | 212273 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 查看 | 2025-07-25 | VERTEX PHARMS INC | 查看 |
| NDA | 217660 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 查看 | 2025-07-25 | VERTEX PHARMS INC | 查看 |
| NDA | 217660 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 查看 | 2025-07-25 | VERTEX PHARMS INC | 查看 |
| NDA | 212273 | TRIKAFTA (COPACKAGED) | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | 查看 | 2025-07-25 | VERTEX PHARMS INC | 查看 |
| NDA | 022212 | DUREZOL | DIFLUPREDNATE | 查看 | 2025-07-25 | SANDOZ | 查看 |
| NDA | 219155 | ANZUPGO | DELGOCITINIB | 查看 | 2025-07-25 | LEO PHARMA AS | 查看 |
| NDA | 205437 | OTEZLA | APREMILAST | 查看 | 2025-07-25 | AMGEN INC | 查看 |
| NDA | 021539 | ACETADOTE | ACETYLCYSTEINE | 查看 | 2025-07-25 | CUMBERLAND PHARMS | 查看 |
| NDA | 219757 | VOSTALLY | RAMIPRIL | 查看 | 2025-07-25 | ROSEMONT PHARMACEUTICALS INC | 查看 |
| NDA | 022306 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 查看 | 2025-07-25 | ALTATHERA PHARMS LLC | 查看 |
| NDA | 215039 | VIJOICE | ALPELISIB | 查看 | 2025-07-24 | NOVARTIS | 查看 |
| NDA | 218466 | VIJOICE | ALPELISIB | 查看 | 2025-07-24 | NOVARTIS | 查看 |
| BLA | 125514 | KEYTRUDA | PEMBROLIZUMAB | 查看 | 2025-07-24 | MERCK SHARP DOHME | 查看 |
