Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 061773
Company: ACS DOBFAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFZOL CEFAZOLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFZOL CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFZOL CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFZOL CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
KEFZOL CEFAZOLIN SODIUM EQ 20GM 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
11/02/1973 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
05/29/2008 SUPPL-66 Labeling

Label is not available on this site.

09/18/2002 SUPPL-63 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/03/1999 SUPPL-59 Labeling

Label is not available on this site.

03/03/1999 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/15/1993 SUPPL-56 Labeling

Label is not available on this site.

04/02/1993 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

10/07/1992 SUPPL-53 Labeling

Label is not available on this site.

06/29/1992 SUPPL-52 Labeling

Label is not available on this site.

10/29/1991 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

07/10/1991 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/29/1991 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-48 Labeling

Label is not available on this site.

11/21/1991 SUPPL-47 Labeling

Label is not available on this site.

07/25/1991 SUPPL-46 Labeling

Label is not available on this site.

07/10/1991 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English