CEFZIL از شرکت CORDEN PHARMA

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CEFZIL از شرکت CORDEN PHARMA

New Drug Application (NDA): 050665

Company: CORDEN PHARMA

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CEFZILCEFPROZIL125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**FOR SUSPENSION;ORALDiscontinued

None

YesNo
CEFZILCEFPROZIL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**FOR SUSPENSION;ORALDiscontinued

None

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
06/23/2004ORIG-23 Approval

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

12/23/1991ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
11/22/2016SUPPL-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

09/14/2007SUPPL-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

06/23/2004SUPPL-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

10/01/2001SUPPL-22 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

05/29/1997SUPPL-17 Labeling

Label is not available on this site.

04/23/1997SUPPL-16 Labeling

Label is not available on this site.

08/26/1997SUPPL-15 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

12/26/1995SUPPL-12 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf

05/09/1995SUPPL-11 Labeling

Label is not available on this site.

02/08/1995SUPPL-10 Labeling

Label is not available on this site.

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

Label is not available on this site.

08/31/1995SUPPL-8 Labeling

Label is not available on this site.

08/31/1995SUPPL-7 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
11/22/2016SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf
09/14/2007SUPPL-24

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf
06/23/2004SUPPL-23

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf
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