Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050461
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ANCEF CEFAZOLIN SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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ANCEF CEFAZOLIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ANCEF CEFAZOLIN SODIUM EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ANCEF CEFAZOLIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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

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

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