Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050547
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLAFORAN CEFOTAXIME SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CLAFORAN CEFOTAXIME SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CLAFORAN CEFOTAXIME SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CLAFORAN CEFOTAXIME SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
03/11/1981 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/23/2015 SUPPL-71 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/2015/050547s071,050596s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf
02/21/2014 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf
09/09/2011 SUPPL-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf
05/27/2009 SUPPL-67 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf
02/21/2008 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050547s066ltr.pdf
09/02/2004 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547s061ltr.pdf
06/23/2004 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf
02/22/2002 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

09/06/2001 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/2001 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

04/10/2001 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/16/1998 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/1998 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/28/1997 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1998 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/2002 SUPPL-47 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf
04/24/1997 SUPPL-45 Labeling

Label is not available on this site.

12/23/1996 SUPPL-44 Labeling

Label is not available on this site.

09/27/1996 SUPPL-42 Efficacy-New Dosing Regimen

Label is not available on this site.

08/25/1995 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1996 SUPPL-38 Labeling

Label is not available on this site.

06/29/1982 SUPPL-35 Labeling

Label is not available on this site.

07/26/1982 SUPPL-34 Labeling

Label is not available on this site.

02/23/1982 SUPPL-33 Labeling

Label is not available on this site.

02/05/1982 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/1981 SUPPL-30 Labeling

Label is not available on this site.

10/05/1981 SUPPL-29 Labeling

Label is not available on this site.

07/22/1981 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/20/1993 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1994 SUPPL-25 Labeling

Label is not available on this site.

09/14/1994 SUPPL-24 Labeling

Label is not available on this site.

11/12/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/19/1993 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1994 SUPPL-21 Labeling

Label is not available on this site.

08/17/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/30/1992 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/19/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-15 Labeling

Label is not available on this site.

08/07/1989 SUPPL-14 Labeling

Label is not available on this site.

06/20/1988 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/13/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/14/1987 SUPPL-11 Labeling

Label is not available on this site.

10/25/1985 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/16/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/14/1984 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/29/1984 SUPPL-5 Labeling

Label is not available on this site.

08/23/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/29/1983 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/23/2015 SUPPL-71 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/2015/050547s071,050596s042lbl.pdf
02/21/2014 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf
09/09/2011 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf
02/21/2008 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf

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