Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065306
Company: ACS DOBFAR
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 No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE;INJECTION Prescription None 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
10/22/2008 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
12/02/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/13/2013 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

08/18/2014 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

05/26/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

07/20/2010 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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

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