Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050578
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTAZ CEFTAZIDIME 500MG/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
FORTAZ CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
FORTAZ CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
FORTAZ CEFTAZIDIME 6GM/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
07/19/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050578Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2017 SUPPL-61 Labeling-Package Insert, Labeling-Container/Carton Labels 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/2017/050578s061,050634s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050578Orig1s061,050634Orig1s028ltr.pdf
03/03/2015 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

09/24/2014 SUPPL-55 Labeling-Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf
07/09/2007 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf
03/14/2007 SUPPL-51 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf
05/19/2004 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf
10/23/2002 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2002 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf
03/29/2002 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf
11/25/1997 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1997 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/24/1996 SUPPL-37 Labeling

Label is not available on this site.

10/04/1996 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/20/1996 SUPPL-34 Labeling

Label is not available on this site.

06/20/1996 SUPPL-33 Labeling

Label is not available on this site.

01/26/1998 SUPPL-32 Labeling

Label is not available on this site.

08/20/1996 SUPPL-31 Labeling

Label is not available on this site.

09/11/1996 SUPPL-30 Labeling

Label is not available on this site.

02/18/1993 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/31/1992 SUPPL-28 Labeling

Label is not available on this site.

10/20/1994 SUPPL-27 Labeling

Label is not available on this site.

08/09/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/13/1992 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1994 SUPPL-22 Labeling

Label is not available on this site.

02/13/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/10/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/29/1993 SUPPL-17 Labeling

Label is not available on this site.

04/29/1993 SUPPL-15 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2017 SUPPL-61 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/2017/050578s061,050634s028lbl.pdf
07/28/2017 SUPPL-61 Labeling-Container/Carton Labels 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/2017/050578s061,050634s028lbl.pdf
09/24/2014 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf
09/24/2014 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf
07/09/2007 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf
03/14/2007 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf
05/19/2004 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf
03/29/2002 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf

FORTAZ

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FORTAZ CEFTAZIDIME 500MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 050578 TELIGENT
TAZICEF CEFTAZIDIME 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 062662 HOSPIRA

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTAZIDIME CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 062640 ACS DOBFAR
CEFTAZIDIME CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 065196 WOCKHARDT
FORTAZ CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050578 TELIGENT
TAZICEF CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 062662 HOSPIRA
TAZICEF CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription No AP 064032 HOSPIRA

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTAZIDIME CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 062640 ACS DOBFAR
FORTAZ CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050578 TELIGENT
TAZICEF CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 062662 HOSPIRA
TAZICEF CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 064032 HOSPIRA

INJECTABLE;INJECTION; 6GM/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTAZIDIME CEFTAZIDIME 6GM/VIAL INJECTABLE;INJECTION Prescription No AP 062640 ACS DOBFAR
FORTAZ CEFTAZIDIME 6GM/VIAL INJECTABLE;INJECTION Prescription Yes AP 050578 TELIGENT
TAZICEF CEFTAZIDIME 6GM/VIAL INJECTABLE;INJECTION Prescription No AP 062662 HOSPIRA

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