Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050643
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINACEF IN PLASTIC CONTAINER CEFUROXIME SODIUM EQ 15MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
ZINACEF IN PLASTIC CONTAINER CEFUROXIME SODIUM EQ 30MG 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
04/29/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/25/2014 SUPPL-22 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-21 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-15 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
11/09/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/2001 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf
07/12/2001 SUPPL-10 Labeling

Label is not available on this site.

12/23/1996 SUPPL-9 Labeling

Label is not available on this site.

09/11/1996 SUPPL-8 Labeling

Label is not available on this site.

12/23/1996 SUPPL-7 Labeling

Label is not available on this site.

09/29/1995 SUPPL-6 Labeling

Label is not available on this site.

10/27/1994 SUPPL-5 Labeling

Label is not available on this site.

02/06/1995 SUPPL-4 Labeling

Label is not available on this site.

03/30/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-2 Labeling

Label is not available on this site.

01/15/1993 SUPPL-1 Manufacturing (CMC)-Control

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-22 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-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf
05/19/2004 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf
10/12/2001 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf

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