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
CEFDINIR از شرکت ALKEM LABS LTD
Abbreviated New Drug Application (ANDA): 210534
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | No |
| CEFDINIR | CEFDINIR | 250MG/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 |
|---|---|---|---|---|---|---|---|
| 02/19/2021 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CEFDINIR
FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210534 | ALKEM LABS LTD |
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065473 | AUROBINDO PHARMA |
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065259 | LUPIN |
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065429 | ORCHID HLTHCARE |
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065337 | SANDOZ |
| CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065332 | TEVA PHARMS |
FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210534 | ALKEM LABS LTD |
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065473 | AUROBINDO PHARMA |
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065259 | LUPIN |
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065429 | ORCHID HLTHCARE |
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065337 | SANDOZ |
| CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065332 | TEVA PHARMS |
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