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): 050664

Company: CORDEN PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFZIL CEFPROZIL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued

None

Yes No
CEFZIL CEFPROZIL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued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
12/23/1991 ORIG-1 Approval

Type 1 – New Molecular Entity

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

04/19/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/10/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/2001 SUPPL-20 Labeling

Label is not available on this site.

02/18/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1998 SUPPL-18 Manufacturing (CMC)-Control

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.

09/05/1996 SUPPL-14 Efficacy-New Indication

Label is not available on this site.

12/26/1995 SUPPL-13 Labeling

Label is not available on this site.

04/10/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1995 SUPPL-11 Labeling

Label is not available on this site.

11/10/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/06/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/21/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/31/1995 SUPPL-7 Labeling

Label is not available on this site.

08/31/1995 SUPPL-6 Labeling

Label is not available on this site.

07/23/1993 SUPPL-5 Manufacturing (CMC)-Control

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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