Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050558
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINACEF CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AB Yes Yes
ZINACEF CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
ZINACEF CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes 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
10/19/1983 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2015 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

08/14/2013 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

09/25/2014 SUPPL-69 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf
07/30/2007 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf
05/19/2004 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf
10/23/2002 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/2001 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2001 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/2001 SUPPL-50 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf
07/12/2001 SUPPL-49 Labeling

Label is not available on this site.

04/03/1997 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

12/23/1996 SUPPL-47 Labeling

Label is not available on this site.

10/31/1995 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/11/1996 SUPPL-45 Labeling

Label is not available on this site.

12/23/1996 SUPPL-44 Labeling

Label is not available on this site.

09/29/1995 SUPPL-43 Labeling

Label is not available on this site.

06/28/1993 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1994 SUPPL-41 Labeling

Label is not available on this site.

12/31/1992 SUPPL-40 Labeling

Label is not available on this site.

02/06/1995 SUPPL-37 Labeling

Label is not available on this site.

02/18/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/23/1992 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

02/13/1992 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1995 SUPPL-31 Labeling

Label is not available on this site.

11/04/1992 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1992 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1992 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1990 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/30/1989 SUPPL-26 Labeling

Label is not available on this site.

03/24/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1987 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1987 SUPPL-23 Labeling

Label is not available on this site.

08/13/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-20 Labeling

Label is not available on this site.

10/23/1986 SUPPL-19 Labeling

Label is not available on this site.

05/30/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1986 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/23/1986 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/25/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/27/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/11/1984 SUPPL-8 Labeling

Label is not available on this site.

04/18/1984 SUPPL-7 Labeling

Label is not available on this site.

03/05/1984 SUPPL-6 Labeling

Label is not available on this site.

02/17/1984 SUPPL-5 Labeling

Label is not available on this site.

02/08/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/22/1983 SUPPL-2 Labeling

Label is not available on this site.

12/07/1983 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2014 SUPPL-69 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf
07/30/2007 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf
05/19/2004 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf
10/12/2001 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf

ZINACEF

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

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 AB 064125 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AB 065048 HIKMA FARMACEUTICA
ZINACEF CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription Yes AB 050558 TELIGENT

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

INJECTABLE;INJECTION; EQ 7.5GM 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 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064124 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065046 HIKMA FARMACEUTICA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065484 HOSPIRA INC
ZINACEF CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 TELIGENT

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