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
CIPROFLOXACIN IN DEXTROSE 5% از شرکت HIKMA FARMACEUTICA
Abbreviated New Drug Application (ANDA): 076757
Company: HIKMA FARMACEUTICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN IN DEXTROSE 5% | CIPROFLOXACIN | 200MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/21/2008 | 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 |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/18/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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