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
CEFADROXIL از شرکت LUPIN
Abbreviated New Drug Application (ANDA): 065396
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription |
AB |
No | No |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 02/21/2008 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/18/2014 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/18/2014 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065396Orig1s012lbl.pdf | |
| 02/21/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065396s000lbl.pdf |
CEFADROXIL
FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065349 | AUROBINDO |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 091036 | HIKMA PHARMS |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065396 | LUPIN |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065307 | ORCHID HLTHCARE |
FOR SUSPENSION;ORAL; EQ 500MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065349 | AUROBINDO |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 091036 | HIKMA PHARMS |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065396 | LUPIN |
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065307 | ORCHID HLTHCARE |
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