Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062640
Company: ACS DOBFAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTAZIDIME CEFTAZIDIME 500MG/VIAL INJECTABLE;INJECTION Discontinued None No No
CEFTAZIDIME CEFTAZIDIME 1GM/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFTAZIDIME CEFTAZIDIME 2GM/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFTAZIDIME CEFTAZIDIME 6GM/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
11/20/1985 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
02/11/2013 SUPPL-34 Labeling-Container/Carton Labels

Label is not available on this site.

03/16/2012 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

04/07/2009 SUPPL-30 Labeling

Label is not available on this site.

09/08/2006 SUPPL-24 Labeling

Label is not available on this site.

07/15/1996 SUPPL-21 Labeling

Label is not available on this site.

08/15/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/26/1996 SUPPL-19 Labeling

Label is not available on this site.

10/18/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/03/1992 SUPPL-15 Labeling

Label is not available on this site.

02/14/1992 SUPPL-14 Labeling

Label is not available on this site.

02/14/1992 SUPPL-13 Labeling

Label is not available on this site.

02/14/1992 SUPPL-10 Labeling

Label is not available on this site.

08/26/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/04/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

CEFTAZIDIME

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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