Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050596
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 40MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CEFOTAXIME SODIUM EQ 40MG BASE/ML 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
05/20/1985 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
03/23/2015 SUPPL-42 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
04/21/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/21/2014 SUPPL-40 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
05/03/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/09/2011 SUPPL-37 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-36 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-35 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/2008/050596s035ltr.pdf
09/02/2004 SUPPL-31 Labeling

Label is not available on this site.

06/23/2004 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf
09/06/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

04/12/2001 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/10/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/18/2002 SUPPL-23 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-22 Labeling

Label is not available on this site.

12/23/1996 SUPPL-20 Labeling

Label is not available on this site.

04/30/1996 SUPPL-18 Labeling

Label is not available on this site.

09/02/1994 SUPPL-17 Labeling

Label is not available on this site.

09/14/1994 SUPPL-16 Labeling

Label is not available on this site.

06/16/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/22/1994 SUPPL-13 Labeling

Label is not available on this site.

05/19/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-10 Labeling

Label is not available on this site.

08/10/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1989 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1992 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/23/1985 SUPPL-3 Labeling

Label is not available on this site.

09/23/1985 SUPPL-2 Labeling

Label is not available on this site.

06/13/1985 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
03/23/2015 SUPPL-42 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-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf
09/09/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf
02/21/2008 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf

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