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
CEFIXIME از شرکت AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 204835
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFIXIME | CEFIXIME | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | No |
| CEFIXIME | CEFIXIME | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 04/14/2015 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204835Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/27/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CEFIXIME
FOR SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFIXIME | CEFIXIME | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211775 | ALKEM LABS LTD |
| CEFIXIME | CEFIXIME | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204835 | AUROBINDO PHARMA LTD |
| CEFIXIME | CEFIXIME | 100MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 206938 | BELCHER |
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFIXIME | CEFIXIME | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211775 | ALKEM LABS LTD |
| CEFIXIME | CEFIXIME | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 204835 | AUROBINDO PHARMA LTD |
| CEFIXIME | CEFIXIME | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 206938 | BELCHER |
| SUPRAX | CEFIXIME | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065355 | LUPIN PHARMS |
نظرات کاربران