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
CEFACLOR از شرکت YUNG SHIN PHARM
Abbreviated New Drug Application (ANDA): 065146
Company: YUNG SHIN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/22/2004 | 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 |
|---|---|---|---|---|---|
| 09/12/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/26/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFACLOR
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065350 | HIKMA |
| CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065146 | YUNG SHIN PHARM |
CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065350 | HIKMA |
| CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065146 | YUNG SHIN PHARM |
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