Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050578
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FORTAZ | CEFTAZIDIME | 500MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| FORTAZ | CEFTAZIDIME | 1GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| FORTAZ | CEFTAZIDIME | 2GM/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| FORTAZ | CEFTAZIDIME | 6GM/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050578Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/11/2020 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050578s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050578Orig1s064ltr.pdf | |
| 02/12/2020 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050578s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050578Orig1s062ltr.pdf | |
| 07/28/2017 | SUPPL-61 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (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/2017/050578s061,050634s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050578Orig1s061,050634Orig1s028ltr.pdf |
| 03/03/2015 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-55 | Labeling, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf | |
| 07/09/2007 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf | |
| 03/14/2007 | SUPPL-51 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf | |
| 05/19/2004 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf | |
| 10/23/2002 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2002 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf |
| 03/29/2002 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf | |
| 11/25/1997 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/1996 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/20/1996 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 10/20/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/09/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2020 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050578s062lbl.pdf | |
| 02/11/2020 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050578s064lbl.pdf | |
| 07/28/2017 | SUPPL-61 | Labeling-Container/Carton Labels | 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/2017/050578s061,050634s028lbl.pdf |
| 07/28/2017 | SUPPL-61 | 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/2017/050578s061,050634s028lbl.pdf |
| 09/24/2014 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf | |
| 09/24/2014 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf | |
| 07/09/2007 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf | |
| 03/14/2007 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf | |
| 05/19/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf | |
| 03/29/2002 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf |