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
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 050780
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/21/2001 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/05/2020 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050780s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050780Orig1s020ltr.pdf |
||
| 05/01/2015 | SUPPL-19 | 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/2015/050780s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf |
|
| 12/12/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2007 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf |
||
| 05/06/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf |
|
| 06/29/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf |
|
| 08/18/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/05/2020 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050780s020lbl.pdf | |
| 05/01/2015 | SUPPL-19 |
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/2015/050780s019lbl.pdf |
| 09/10/2007 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf | |
| 02/21/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf |
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
INJECTABLE;INJECTION; EQ 750MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050780 | B BRAUN |
INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050780 | B BRAUN |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064125 | ACS DOBFAR SPA |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065048 | HIKMA FARMACEUTICA |
| ZINACEF | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050558 | TELIGENT |
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