Drugs@FDA: FDA-Approved Drugs
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZINACEF | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |
| ZINACEF | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZINACEF | CEFUROXIME SODIUM | EQ 7.5GM BASE/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 |
|---|---|---|---|---|---|---|---|
| 10/19/1983 | 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 |
|---|---|---|---|---|---|
| 05/16/2021 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050558s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050558Orig1s076ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050558Orig1s076ltr.pdf | |
| 02/11/2020 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050558s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050558Orig1s075ltr.pdf | |
| 03/16/2015 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/2013 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-69 | 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/2014/050558s069,050643s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf |
| 07/30/2007 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf | |
| 05/19/2004 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf | |
| 10/23/2002 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/2001 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/2001 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/2001 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-50 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf | |
| 07/12/2001 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/31/1995 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/29/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 06/28/1993 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1994 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/31/1992 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 02/06/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/18/1993 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1992 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1991 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/04/1992 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1992 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1987 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/30/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1986 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/23/1986 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/25/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/18/1984 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/05/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/08/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/07/1983 | 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 |
|---|---|---|---|---|---|
| 05/16/2021 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050558s076lbl.pdf | |
| 02/11/2020 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050558s075lbl.pdf | |
| 09/25/2014 | SUPPL-69 | 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/2014/050558s069,050643s022lbl.pdf |
| 07/30/2007 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf | |
| 05/19/2004 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf | |
| 10/12/2001 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf |