Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065483
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No No
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
10/15/2008 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
04/12/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CEFUROXIME SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065483 HOSPIRA INC

INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050780 B BRAUN
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064125 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065048 HIKMA FARMACEUTICA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065483 HOSPIRA INC
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065503 HOSPIRA INC
ZINACEF CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 TELIGENT

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