Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050665
Company: CORDEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFZIL CEFPROZIL 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No
CEFZIL CEFPROZIL 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SUSPENSION;ORAL Discontinued None Yes No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
06/23/2004 ORIG-23 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

12/23/1991 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
11/22/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050664Orig1s026,050665Orig1s026ltr.pdf
09/14/2007 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf
06/23/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf
10/01/2001 SUPPL-22 Labeling

Label is not available on this site.

04/15/1999 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1999 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/29/1997 SUPPL-17 Labeling

Label is not available on this site.

04/23/1997 SUPPL-16 Labeling

Label is not available on this site.

08/26/1997 SUPPL-15 Labeling

Label is not available on this site.

02/07/1996 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/1996 SUPPL-13 Efficacy-New Indication

Label is not available on this site.

12/26/1995 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf
05/09/1995 SUPPL-11 Labeling

Label is not available on this site.

02/08/1995 SUPPL-10 Labeling

Label is not available on this site.

04/10/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1995 SUPPL-8 Labeling

Label is not available on this site.

08/31/1995 SUPPL-7 Labeling

Label is not available on this site.

12/07/1993 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1993 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/17/1995 SUPPL-4 Efficacy-New Patient Population

Label is not available on this site.

12/31/1992 SUPPL-2 Efficacy-New Patient Population

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/22/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf
09/14/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf
06/23/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf

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