Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065369
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFEPIME HYDROCHLORIDE CEFEPIME HYDROCHLORIDE EQ 2GM 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
06/18/2007 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/065369s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/065369_original_approval_pkg.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/27/2008 SUPPL-4 Labeling

Label is not available on this site.

02/07/2008 SUPPL-2 Labeling

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