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 HIKMA FARMACEUTICA
Abbreviated New Drug Application (ANDA): 076717
Company: HIKMA FARMACEUTICA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/22/2009 | 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-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/16/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/15/2018 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-1 | Labeling-Package Insert |
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 |
منبع : www.accessdata.fda.gov
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