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
CEFPROZIL از شرکت APOTEX INC
Abbreviated New Drug Application (ANDA): 065327
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/26/2008 | 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 |
|---|---|---|---|---|---|
| 06/01/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CEFPROZIL
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065327 | APOTEX INC |
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065340 | AUROBINDO PHARMA LTD |
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065235 | CHARTWELL RX |
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065276 | LUPIN |
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065267 | ORCHID HLTHCARE |
| CEFPROZIL | CEFPROZIL | 250MG | TABLET;ORAL | Prescription | No | AB | 065208 | TEVA |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065327 | APOTEX INC |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065340 | AUROBINDO PHARMA LTD |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065235 | CHARTWELL RX |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065276 | LUPIN |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065267 | ORCHID HLTHCARE |
| CEFPROZIL | CEFPROZIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065208 | TEVA |
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