FDA 药品与器械查询
实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。
数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。
支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。
查询美国市场在售药品：剂型、给药途径、活性成分、持证商与 NDC 编码，用于判断目标品种在美国是否已有同类上市。
已将中文关键词转为英文「atorvastatin」检索 FDA 数据库。
共找到 521 条与「atorvastatin」匹配的结果
当前展示 50 条美国 FDA 上市药品记录； 海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›
| 药品名称 | NDC 编码 | 剂型 | 给药途径 | 活性成分 | 持证商 | 上市类别 |
|---|---|---|---|---|---|---|
Amlodipine and Atorvastatin | 46708-762 | TABLET, FILM COATED | ORAL | AMLODIPINE BESYLATE 10 mg/1；ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Alembic Pharmaceuticals Limited | ANDA |
Amlodipine and Atorvastatin | 46708-759 | TABLET, FILM COATED | ORAL | AMLODIPINE BESYLATE 5 mg/1；ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Alembic Pharmaceuticals Limited | ANDA |
Amlodipine and Atorvastatin | 46708-760 | TABLET, FILM COATED | ORAL | AMLODIPINE BESYLATE 5 mg/1；ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Alembic Pharmaceuticals Limited | ANDA |
ATORVASTATIN CALCIUM | 70518-1322 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 | REMEDYREPACK INC. | ANDA |
ATORVASTATIN CALCIUM | 72162-2238 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Bryant Ranch Prepack | ANDA |
Amlodipine and Atorvastatin | 46708-761 | TABLET, FILM COATED | ORAL | AMLODIPINE BESYLATE 5 mg/1；ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | Alembic Pharmaceuticals Limited | ANDA |
ATORVASTATIN CALCIUM | 68071-3701 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | NuCare Pharmaceuticals, Inc. | ANDA |
ATORVASTATIN CALCIUM | 16729-044 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Accord Healthcare Inc. | ANDA |
atorvastatin calcium | 50090-7724 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | A-S Medication Solutions | ANDA |
atorvastatin calcium | 50090-7721 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | A-S Medication Solutions | ANDA |
ATORVASTATIN CALCIUM | 67046-1526 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Coupler LLC | ANDA |
ATORVASTATIN CALCIUM | 68071-3267 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | NuCare Pharmaceuticals, Inc. | ANDA |
Atorvastatin calcium | 70518-3273 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | REMEDYREPACK INC. | ANDA |
Atorvastatin Calcium Amorphous Atorvastatin Calcium Amorphous | 55111-070 | POWDER | — | ATORVASTATIN CALCIUM ANHYDROUS 1 kg/kg | Dr.Reddys Laboratories Limited | BULK INGREDIENT |
atorvastatin calcium | 50090-7722 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | A-S Medication Solutions | ANDA |
ATORVASTATIN CALCIUM | 71610-022 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
atorvastatin calcium | 50090-7723 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | A-S Medication Solutions | ANDA |
ATORVASTATIN CALCIUM | 16729-047 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | Accord Healthcare Inc. | ANDA |
atorvastatin calcium | 50090-7727 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | A-S Medication Solutions | ANDA |
Atorvastatin Calcium | 0093-5058 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Teva Pharmaceuticals USA, Inc. | ANDA |
ATORVASTATIN CALCIUM | 16729-045 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Accord Healthcare Inc. | ANDA |
atorvastatin calcium | 50090-7725 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | A-S Medication Solutions | ANDA |
Atorvastatin calcium | 67046-1529 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Coupler LLC | ANDA |
ATORVASTATIN CALCIUM | 68071-3667 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | NuCare Pharmaceuticals, Inc. | ANDA |
ATORVASTATIN CALCIUM | 16729-046 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Accord Healthcare Inc. | ANDA |
atorvastatin calcium | 50090-7726 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | A-S Medication Solutions | ANDA |
atorvastatin calcium atorvastatin calcium | 65427-156 | TABLET, FILM COATED | — | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Pfizer Pharmaceuticals LLC | EXPORT ONLY |
ATORVASTATIN CALCIUM | 0904-6292 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 | Major Pharmaceuticals | ANDA |
ATORVASTATIN CALCIUM | 71610-036 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
atorvastatin calcium atorvastatin calcium | 65427-155 | TABLET, FILM COATED | — | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Pfizer Pharmaceuticals LLC | EXPORT ONLY |
Atorvastatin Calcium atorvastatin calcium, film coated | 71335-2388 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Bryant Ranch Prepack | ANDA |
Atorvastatin Calcium | 76420-943 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Asclemed USA, Inc. | ANDA |
ATORVASTATIN CALCIUM | 77771-451 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Radha Pharmaceuticals, Inc. | ANDA |
atorvastatin calcium atorvastatin calcium | 65427-255 | TABLET, FILM COATED | — | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Pfizer Pharmaceuticals LLC | EXPORT ONLY |
Atorvastatin Calcium | 0093-5059 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Teva Pharmaceuticals USA, Inc. | ANDA |
Atorvastatin Calcium | 42708-004 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | QPharma, Inc. | ANDA |
ATORVASTATIN CALCIUM | 50090-6505 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 | A-S Medication Solutions | ANDA |
Atorvastatin Calcium | 0480-3585 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Teva Pharmaceuticals, Inc. | ANDA |
atorvastatin calcium atorvastatin calcium | 65427-157 | TABLET, FILM COATED | — | ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 | Pfizer Pharmaceuticals LLC | EXPORT ONLY |
atorvastatin calcium atorvastatin calcium | 65427-158 | TABLET, FILM COATED | — | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | Pfizer Pharmaceuticals LLC | EXPORT ONLY |
Atorvastatin Calcium | 68071-2276 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | NuCare Pharmaceuticals,Inc. | ANDA |
Atorvastatin calcium | 70518-3298 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | REMEDYREPACK INC. | ANDA |
Atorvastatin Calcium | 42708-003 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | QPharma, Inc. | ANDA |
Amlodipine and atorvastatin | 0378-4513 | TABLET, FILM COATED | ORAL | AMLODIPINE BESYLATE 5 mg/1；ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 | Mylan Pharmaceuticals Inc. | ANDA |
Atorvastatin calcium | 70518-3304 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | REMEDYREPACK INC. | ANDA |
Atorvastatin Calcium | 71335-2393 | TABLET | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Bryant Ranch Prepack | ANDA |
Atorvastatin Calcium | 76420-948 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 | Asclemed USA, Inc. | ANDA |
Atorvastatin Calcium | 71335-1010 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Bryant Ranch Prepack | ANDA |
Atorvastatin Calcium | 76420-945 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Asclemed USA, Inc. | ANDA |
ATORVASTATIN CALCIUM | 77771-452 | TABLET, FILM COATED | ORAL | ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 | Radha Pharmaceuticals, Inc. | ANDA |
数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。