| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ZITHROMAX | 050670 | 001 | NDA | AZITHROMYCIN | CAPSULE;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/11/01 | 1991/11/01 | PFIZER | Discontinued |
| ZITHROMAX | 050693 | 001 | NDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 1GM BASE/PACKET | Yes | Yes | 1994/09/28 | 1994/09/28 | PFIZER | Prescription |
| ZITHROMAX | 050710 | 001 | NDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | Yes | No | 1995/10/19 | 1995/10/19 | PFIZER | Prescription |
| ZITHROMAX | 050710 | 002 | NDA | AZITHROMYCIN | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | Yes | Yes | 1995/10/19 | 1995/10/19 | PFIZER | Prescription |
| ZITHROMAX | 050730 | 001 | NDA | AZITHROMYCIN | TABLET;ORAL | EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/06/12 | 1996/06/12 | PFIZER | Discontinued |
| ZITHROMAX | 050711 | 001 | NDA | AZITHROMYCIN | TABLET;ORAL | EQ 250MG BASE | Yes | No | 1996/07/18 | 1996/07/18 | PFIZER | Prescription |
| ZITHROMAX | 050733 | 001 | NDA | AZITHROMYCIN | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | Yes | 1997/01/30 | 1997/01/30 | PFIZER | Prescription |
| TROVAN/ZITHROMAX COMPLIANCE PAK | 050762 | 001 | NDA | AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE | FOR SUSPENSION, TABLET;ORAL | EQ 1GM BASE,N/A;N/A,EQ 100MG BASE | No | No | 1998/12/18 | 1998/12/18 | PFIZER | Discontinued |
| ZITHROMAX | 050784 | 001 | NDA | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | Yes | No | 2002/05/24 | 2002/05/24 | PFIZER | Prescription |