Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050646
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPTAZ CEFTAZIDIME 500MG/VIAL INJECTABLE;INJECTION Discontinued None No No
CEPTAZ CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Discontinued None No No
CEPTAZ CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Discontinued None No No
CEPTAZ CEFTAZIDIME 10GM/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
09/27/1990 ORIG-1 Approval Type 2 - New Active Ingredient 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
02/22/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/29/2002 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf
11/25/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/24/1996 SUPPL-11 Labeling

Label is not available on this site.

06/20/1996 SUPPL-10 Labeling

Label is not available on this site.

06/20/1996 SUPPL-9 Labeling

Label is not available on this site.

01/26/1998 SUPPL-8 Labeling

Label is not available on this site.

08/20/1996 SUPPL-7 Labeling

Label is not available on this site.

09/11/1996 SUPPL-6 Labeling

Label is not available on this site.

10/20/1994 SUPPL-5 Labeling

Label is not available on this site.

09/07/1994 SUPPL-4 Labeling

Label is not available on this site.

08/09/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/10/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1992 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2002 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf

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