Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065247
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/2005 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
01/17/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065247s011lbl.pdf
08/31/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

06/30/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/065247s011lbl.pdf

CEFAZOLIN SODIUM

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065306 ACS DOBFAR
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065143 HIKMA FARMACEUTICA
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065247 HOSPIRA INC
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 209217 QILU PHARM CO LTD
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062831 SANDOZ

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