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 از شرکت BAXTER HLTHCARE CORP
Abbreviated New Drug Application (ANDA): 078062
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 04/29/2008 | 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 |
|---|---|---|---|---|---|
| 05/06/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2019 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2017 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/07/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2012 | SUPPL-8 | Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |
||
| 05/24/2012 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2011 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2010 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/26/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/29/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN
INJECTABLE;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078062 | BAXTER HLTHCARE CORP |
| CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076717 | HIKMA FARMACEUTICA |
| CIPROFLOXACIN | CIPROFLOXACIN | 200MG/20ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077245 | HOSPIRA |
INJECTABLE;INJECTION; 400MG/40ML (10MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078062 | BAXTER HLTHCARE CORP |
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 076717 | HIKMA FARMACEUTICA |
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 077245 | HOSPIRA |
نظرات کاربران