Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050588
Company: TELIGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFOTAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
CEFOTAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes No
CEFOTAN CEFOTETAN DISODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Discontinued None 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
12/27/1985 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050588Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2017 SUPPL-32 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/2017/050588s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050588Orig1s032ltr.pdf
12/09/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/25/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50588slr030ltr.pdf
06/20/2003 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf
03/04/2003 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr027ltr.pdf
08/05/1999 SUPPL-26 Labeling

Label is not available on this site.

10/20/1995 SUPPL-25 Labeling

Label is not available on this site.

09/15/1994 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1993 SUPPL-22 Labeling

Label is not available on this site.

09/12/1995 SUPPL-21 Labeling

Label is not available on this site.

07/30/1993 SUPPL-20 Labeling

Label is not available on this site.

09/29/1992 SUPPL-19 Labeling

Label is not available on this site.

05/18/1992 SUPPL-18 Labeling

Label is not available on this site.

11/25/1991 SUPPL-16 Labeling

Label is not available on this site.

11/25/1991 SUPPL-14 Labeling

Label is not available on this site.

11/25/1991 SUPPL-4 Labeling

Label is not available on this site.

11/25/1991 SUPPL-2 Efficacy-New Dosing Regimen

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2017 SUPPL-32 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/2017/050588s032lbl.pdf
06/25/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf
06/20/2003 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf
03/04/2003 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf

CEFOTAN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFOTAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050588 TELIGENT
CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065374 FRESENIUS KABI USA
CEFOTETAN CEFOTETAN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091031 HIKMA

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFOTAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050588 TELIGENT
CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065374 FRESENIUS KABI USA
CEFOTETAN CEFOTETAN DISODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091031 HIKMA

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