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% IN PLASTIC CONTAINER از شرکت INFORLIFE
Abbreviated New Drug Application (ANDA): 078252
Company: INFORLIFE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | 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 |
|---|---|---|---|---|---|---|---|
| 03/18/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078252s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/16/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/16/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2014 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/17/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-10 | Labeling-Package Insert, REMS-Proposal, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/05/2009 | SUPPL-5 | REMS-Proposal, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/19/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/19/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 078024 | BAXTER HLTHCARE CORP |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 077753 | HOSPIRA |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 078252 | INFORLIFE |
INJECTABLE;INJECTION; 400MG/200ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE;INJECTION | Prescription | No | AP | 078024 | BAXTER HLTHCARE CORP |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE;INJECTION | Prescription | No | AP | 078431 | HIKMA FARMACEUTICA |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE;INJECTION | Prescription | No | AP | 077753 | HOSPIRA |
| CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE;INJECTION | Prescription | No | AP | 078252 | INFORLIFE |
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