| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AZELAIC ACID | 204637 | 001 | ANDA | AZELAIC ACID | GEL;TOPICAL | 15% | No | No | 2018/11/19 | 2018/11/19 | GLENMARK SPECLT | Prescription |
| AZELAIC ACID | 208011 | 001 | ANDA | AZELAIC ACID | GEL;TOPICAL | 15% | No | No | 2018/11/19 | 2018/11/19 | ACTAVIS LABS UT INC | Prescription |
| AZELAIC ACID | 208724 | 001 | ANDA | AZELAIC ACID | GEL;TOPICAL | 15% | No | No | 2018/11/19 | 2018/11/19 | ENCUBE | Prescription |
| AZELAIC ACID | 210549 | 001 | ANDA | AZELAIC ACID | GEL;TOPICAL | 15% | No | No | 2019/08/23 | 2019/08/23 | TARO | Prescription |
| AZELAIC ACID | 210928 | 001 | ANDA | AZELAIC ACID | AEROSOL, FOAM;TOPICAL | 15% | No | No | 2020/10/07 | 2020/10/07 | TEVA PHARMS USA | Discontinued |
| AZELAIC ACID | 212581 | 001 | ANDA | AZELAIC ACID | AEROSOL, FOAM;TOPICAL | 15% | No | No | 2021/04/19 (TA) | -- | TARO PHARM INDS LTD | None (Tentative Approval) |