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 HOSPIRA
Abbreviated New Drug Application (ANDA): 077245
Company: HOSPIRA
| 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 | No |
| CIPROFLOXACIN | CIPROFLOXACIN | 400MG/40ML (10MG/ML) | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 08/28/2006 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077245s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-23 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/22/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/05/2007 | SUPPL-4 | 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 |
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