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 LUPIN
Abbreviated New Drug Application (ANDA): 065261
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | No |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/19/2005 | 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 |
|---|---|---|---|---|---|
| 04/09/2018 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/27/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
CEFPROZIL
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065351 | APOTEX INC |
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065381 | AUROBINDO PHARMA |
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065261 | LUPIN |
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065284 | ORCHID HLTHCARE |
| CEFPROZIL | CEFPROZIL | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065257 | SANDOZ |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065351 | APOTEX INC |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065381 | AUROBINDO PHARMA |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065261 | LUPIN |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065284 | ORCHID HLTHCARE |
| CEFPROZIL | CEFPROZIL | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065257 | SANDOZ |
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