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
CEDAX از شرکت SI PHARMS
New Drug Application (NDA): 050686
Company: SI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEDAX | CEFTIBUTEN DIHYDRATE | EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION;ORAL | Discontinued |
None |
Yes | No |
| CEDAX | CEFTIBUTEN DIHYDRATE | EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 12/20/1995 | 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 |
|---|---|---|---|---|---|
| 03/11/2011 | SUPPL-16 | Manufacturing (CMC) |
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/2011/050686s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf |
|
| 11/04/2010 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf |
|
| 02/10/2009 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf |
||
| 01/04/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/19/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/02/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/16/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/03/1998 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/09/1996 | 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 |
|---|---|---|---|---|---|
| 03/11/2011 | SUPPL-16 |
Manufacturing (CMC) |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf |
| 02/10/2009 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf |
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