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
CEFOTAN از شرکت TELIGENT
New Drug Application (NDA): 050588
Company: TELIGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOTAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | No |
| CEFOTAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | No |
| CEFOTAN | CEFOTETAN DISODIUM | 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 |
|---|---|---|---|---|---|---|---|
| 12/27/1985 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050588Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/2017 | SUPPL-32 | 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/2017/050588s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050588Orig1s032ltr.pdf |
|
| 12/09/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2004 | SUPPL-30 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50588slr030ltr.pdf |
||
| 06/20/2003 | SUPPL-29 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf |
||
| 03/04/2003 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr027ltr.pdf |
||
| 08/05/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/15/1994 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 09/12/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/18/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/09/2017 | SUPPL-32 |
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/2017/050588s032lbl.pdf |
| 06/25/2004 | SUPPL-30 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf | |
| 06/20/2003 | SUPPL-29 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf | |
| 03/04/2003 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf |
CEFOTAN
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOTAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050588 | TELIGENT |
| CEFOTETAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065374 | FRESENIUS KABI USA |
| CEFOTETAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091031 | HIKMA |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOTAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050588 | TELIGENT |
| CEFOTETAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065374 | FRESENIUS KABI USA |
| CEFOTETAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 091031 | HIKMA |
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