Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062831
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM 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
12/09/1988 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
06/24/2016 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

06/24/2016 SUPPL-33 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/15/2013 SUPPL-29 Labeling

Label is not available on this site.

02/12/2008 SUPPL-18 Labeling

Label is not available on this site.

06/01/2006 SUPPL-15 Labeling

Label is not available on this site.

03/05/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/25/1998 SUPPL-8 Labeling

Label is not available on this site.

11/25/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/16/1995 SUPPL-6 Labeling

Label is not available on this site.

09/25/1992 SUPPL-5 Labeling

Label is not available on this site.

07/17/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/18/1991 SUPPL-3 Labeling

Label is not available on this site.

12/15/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/15/1992 SUPPL-1 Labeling

Label is not available on this site.

CEFAZOLIN SODIUM

INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065303 ACS DOBFAR
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065047 HIKMA FARMACEUTICA
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065226 HOSPIRA INC
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062831 SANDOZ

INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065303 ACS DOBFAR
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065047 HIKMA FARMACEUTICA
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065226 HOSPIRA INC
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203661 QILU PHARM CO LTD
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062831 SANDOZ
CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065345 SANDOZ

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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