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
CEFOBID از شرکت PFIZER
New Drug Application (NDA): 050551
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOBID | CEFOPERAZONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEFOBID | CEFOPERAZONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEFOBID | CEFOPERAZONE SODIUM | EQ 10GM BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1982 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 09/18/2020 | SUPPL-46 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050551s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050551Orig1s046ltr.pdf |
||
| 09/28/2017 | SUPPL-45 | 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/2017/050551s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050551Orig1s045ltr.pdf |
|
| 06/18/2018 | SUPPL-44 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050551s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050551Orig1s044ltr.pdf |
||
| 03/18/2015 | SUPPL-43 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050551Orig1s043ltr.pdf |
||
| 12/18/2002 | SUPPL-42 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50551slr042ltr.pdf |
||
| 12/07/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1994 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 09/29/1988 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/05/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2020 | SUPPL-46 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050551s046lbl.pdf | |
| 06/18/2018 | SUPPL-44 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050551s044lbl.pdf | |
| 09/28/2017 | SUPPL-45 |
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/2017/050551s045lbl.pdf |
| 03/18/2015 | SUPPL-43 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050551s043lbl.pdf | |
| 12/18/2002 | SUPPL-42 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50551slr042_Cefobid_lbl.pdf |
نظرات کاربران