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
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER از شرکت VALIDUS PHARMS
New Drug Application (NDA): 050596
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOTAXIME SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 05/20/1985 | 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 |
|---|---|---|---|---|---|
| 03/23/2015 | SUPPL-42 | Labeling-Package Insert |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf |
|
| 04/21/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2014 | SUPPL-40 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf |
||
| 05/03/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/2011 | SUPPL-37 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf |
||
| 05/27/2009 | SUPPL-36 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf |
|
| 02/21/2008 | SUPPL-35 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf |
||
| 09/02/2004 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/23/2004 | SUPPL-30 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf |
|
| 09/06/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf |
|
| 04/24/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/02/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/10/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1992 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/23/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/23/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/23/2015 | SUPPL-42 |
Labeling-Package Insert |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf |
| 02/21/2014 | SUPPL-40 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf | |
| 09/09/2011 | SUPPL-37 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf | |
| 02/21/2008 | SUPPL-35 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf |
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