Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050589
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER CEFTIZOXIME SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER CEFTIZOXIME SODIUM EQ 40MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CEFIZOX IN PLASTIC CONTAINER CEFTIZOXIME SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CEFIZOX IN PLASTIC CONTAINER CEFTIZOXIME SODIUM EQ 40MG BASE/ML 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
10/03/1984 ORIG-1 Approval Type 3 - New Dosage Form 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
01/14/2005 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf
02/26/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1993 SUPPL-11 Labeling

Label is not available on this site.

09/25/1992 SUPPL-10 Labeling

Label is not available on this site.

04/13/1995 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

02/06/1992 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1992 SUPPL-6 Labeling

Label is not available on this site.

03/13/2009 SUPPL-5 Labeling

Label is not available on this site.

02/06/1992 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1986 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/15/1985 SUPPL-2 Labeling

Label is not available on this site.

04/16/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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