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
CEFZIL از شرکت CORDEN PHARMA
New Drug Application (NDA): 050665
Company: CORDEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFZIL | CEFPROZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION;ORAL | Discontinued |
None |
Yes | No |
| CEFZIL | CEFPROZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/2004 | ORIG-23 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
|
| 12/23/1991 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/22/2016 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050664Orig1s026,050665Orig1s026ltr.pdf |
||
| 09/14/2007 | SUPPL-24 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf |
||
| 06/23/2004 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf |
||
| 10/01/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/23/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/26/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1996 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/26/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf |
|
| 05/09/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/10/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/31/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/07/1993 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1993 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/17/1995 | SUPPL-4 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/22/2016 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf | |
| 09/14/2007 | SUPPL-24 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf | |
| 06/23/2004 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf |
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