Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050560
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFIZOX CEFTIZOXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFIZOX CEFTIZOXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFIZOX CEFTIZOXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFIZOX CEFTIZOXIME SODIUM EQ 10GM 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
09/15/1983 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
08/07/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

01/14/2005 SUPPL-51 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf
02/13/1996 SUPPL-50 Labeling

Label is not available on this site.

12/14/1995 SUPPL-49 Labeling

Label is not available on this site.

07/10/1995 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

03/19/1993 SUPPL-46 Labeling

Label is not available on this site.

01/22/1992 SUPPL-43 Labeling

Label is not available on this site.

05/05/1989 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1992 SUPPL-36 Efficacy-New Indication

Label is not available on this site.

04/29/1987 SUPPL-33 Manufacturing (CMC)-Expiration Date

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