Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050634
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORTAZ IN PLASTIC CONTAINER CEFTAZIDIME SODIUM EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
FORTAZ IN PLASTIC CONTAINER CEFTAZIDIME SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Discontinued None Yes No
FORTAZ IN PLASTIC CONTAINER CEFTAZIDIME SODIUM EQ 40MG BASE/ML INJECTABLE;INJECTION Discontinued None Yes 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
04/28/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
07/28/2017 SUPPL-28 Labeling-Container/Carton Labels, 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/2017/050578s061,050634s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050578Orig1s061,050634Orig1s028ltr.pdf
04/11/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/29/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/24/2014 SUPPL-23 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-20 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-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s051,050634s018lbl.pdf
05/19/2004 SUPPL-16 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
02/22/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2002 SUPPL-14 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-12 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-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1996 SUPPL-10 Labeling

Label is not available on this site.

09/11/1996 SUPPL-9 Labeling

Label is not available on this site.

06/20/1996 SUPPL-8 Labeling

Label is not available on this site.

06/20/1996 SUPPL-7 Labeling

Label is not available on this site.

01/26/1998 SUPPL-6 Labeling

Label is not available on this site.

08/20/1996 SUPPL-5 Labeling

Label is not available on this site.

10/20/1994 SUPPL-4 Labeling

Label is not available on this site.

11/08/1993 SUPPL-3 Labeling

Label is not available on this site.

03/01/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1994 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
07/28/2017 SUPPL-28 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
07/28/2017 SUPPL-28 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
09/24/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf
09/24/2014 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf
07/09/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf
03/14/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf
05/19/2004 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf
03/29/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf

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