Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANCEF | CEFAZOLIN SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANCEF | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANCEF | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANCEF | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ANCEF | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/04/1973 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2004 | SUPPL-139 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr139ltr.pdf | |
| 01/06/2005 | SUPPL-138 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50461s138ltr.pdf |
| 01/15/2004 | SUPPL-135 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr135_ancef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr135ltr.pdf | |
| 05/21/2002 | SUPPL-134 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1999 | SUPPL-133 | Labeling |
Label is not available on this site. |
||
| 01/04/1994 | SUPPL-132 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1992 | SUPPL-130 | Labeling |
Label is not available on this site. |
||
| 05/29/1992 | SUPPL-129 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1982 | SUPPL-128 | Labeling |
Label is not available on this site. |
||
| 07/12/1982 | SUPPL-127 | Labeling |
Label is not available on this site. |
||
| 07/12/1982 | SUPPL-126 | Labeling |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-125 | Labeling |
Label is not available on this site. |
||
| 06/04/1982 | SUPPL-124 | Labeling |
Label is not available on this site. |
||
| 05/18/1982 | SUPPL-123 | Labeling |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-122 | Labeling |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-121 | Labeling |
Label is not available on this site. |
||
| 04/20/1982 | SUPPL-120 | Labeling |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-119 | Labeling |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-118 | Labeling |
Label is not available on this site. |
||
| 01/04/1982 | SUPPL-117 | Labeling |
Label is not available on this site. |
||
| 11/27/1981 | SUPPL-116 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1981 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
| 09/01/1981 | SUPPL-114 | Labeling |
Label is not available on this site. |
||
| 08/11/1981 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
| 07/23/1981 | SUPPL-112 | Labeling |
Label is not available on this site. |
||
| 06/10/1981 | SUPPL-111 | Labeling |
Label is not available on this site. |
||
| 04/08/1981 | SUPPL-110 | Labeling |
Label is not available on this site. |
||
| 06/19/1981 | SUPPL-109 | Labeling |
Label is not available on this site. |
||
| 03/12/1981 | SUPPL-108 | Labeling |
Label is not available on this site. |
||
| 02/11/1981 | SUPPL-107 | Labeling |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-106 | Labeling |
Label is not available on this site. |
||
| 07/17/1980 | SUPPL-105 | Labeling |
Label is not available on this site. |
||
| 03/05/1980 | SUPPL-104 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
| 05/15/1979 | SUPPL-101 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1979 | SUPPL-99 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/28/1978 | SUPPL-98 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1978 | SUPPL-97 | Labeling |
Label is not available on this site. |
||
| 10/18/1978 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 09/29/1978 | SUPPL-95 | Labeling |
Label is not available on this site. |
||
| 08/28/1978 | SUPPL-94 | Labeling |
Label is not available on this site. |
||
| 08/22/1978 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 08/17/1978 | SUPPL-92 | Labeling |
Label is not available on this site. |
||
| 08/10/1978 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 07/25/1978 | SUPPL-90 | Labeling |
Label is not available on this site. |
||
| 05/23/1978 | SUPPL-89 | Labeling |
Label is not available on this site. |
||
| 05/23/1978 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1978 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1977 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 10/14/1977 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 06/09/1977 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 05/22/1978 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 10/08/1976 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 08/12/1976 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 08/05/1976 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 07/08/1976 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1976 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 06/08/1976 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 05/10/1976 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1976 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/1976 | SUPPL-74 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/15/1976 | SUPPL-73 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1976 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1976 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 02/26/1976 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 11/20/1975 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1975 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1975 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1975 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 06/08/1977 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 07/07/1975 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 05/12/1975 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 04/29/1975 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 04/10/1975 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 04/10/1975 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 02/25/1975 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 02/18/1975 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 12/24/1974 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 09/26/1974 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 09/26/1974 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1974 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1974 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 03/15/1974 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1974 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 06/22/1992 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1991 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1992 | SUPPL-45 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1990 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2004 | SUPPL-139 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf | |
| 01/15/2004 | SUPPL-135 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr135_ancef_lbl.pdf |