اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHLORAMPHENICOL SODIUM SUCCINATE از شرکت FRESENIUS KABI USA
Abbreviated New Drug Application (ANDA): 062365
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORAMPHENICOL SODIUM SUCCINATE | CHLORAMPHENICOL SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
None |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/25/1982 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/01/2016 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/08/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/15/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/10/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/23/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
نظرات کاربران