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 LUPIN
Abbreviated New Drug Application (ANDA): 065259
Company: LUPIN
| 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 |
|---|---|---|---|---|---|---|---|
| 05/31/2006 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065259s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2010 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/11/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/13/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/11/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/07/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/07/2007 | SUPPL-1 | Manufacturing (CMC)-New Strength |
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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