CEFTIN از شرکت GLAXOSMITHKLINE

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

CEFTIN از شرکت GLAXOSMITHKLINE

New Drug Application (NDA): 050672

Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTIN CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Discontinued

None

Yes No
CEFTIN CEFUROXIME AXETIL EQ 250MG BASE/5ML 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
06/30/1994 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
03/05/2021 SUPPL-38 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050605s052,050672s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050605Orig1s052; 050672Orig1s038ltr.pdf

04/25/2019 SUPPL-37 Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051; 50672Orig1s037ltr.pdf

10/13/2017 SUPPL-36 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/2017/050605s050,050672s036lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050605Orig1s050,050672Orig1s36ltr.pdf

11/22/2016 SUPPL-35 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050605Orig1s049,050672Orig1s035ltr.pdf

08/26/2015 SUPPL-34 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s048,050672Orig1s034ltr.pdf

06/26/2015 SUPPL-33 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050605Orig1s047,050672Orig1s033ltr.pdf

09/20/2014 SUPPL-32 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf

09/20/2014 SUPPL-29 Labeling-Package Insert, Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050672Orig1s029,s032ltr.pdf

08/01/2007 SUPPL-28 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050672s028ltr.pdf

06/03/2004 SUPPL-25 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50605slr039,50672slr025ltr.pdf

09/18/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/11/2002 SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s33ltr.pdf

09/25/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/02/1999 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1999 SUPPL-14 Efficacy-Labeling Change With Clinical Data

Letter (PDF)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50605ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50605S032_Ceftin.pdf

03/29/2002 SUPPL-13 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50605s31ltr.pdf

03/24/1998 SUPPL-12 Labeling

Label is not available on this site.

11/19/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/04/1997 SUPPL-10 Labeling

Label is not available on this site.

12/23/1996 SUPPL-9 Labeling

Label is not available on this site.

04/29/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-7 Labeling

Label is not available on this site.

08/08/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1996 SUPPL-5 Labeling

Label is not available on this site.

12/23/1996 SUPPL-4 Labeling

Label is not available on this site.

07/27/1999 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/14/1995 SUPPL-2 Labeling

Label is not available on this site.

09/13/1996 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
03/05/2021 SUPPL-38

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050605s052,050672s038lbl.pdf
10/13/2017 SUPPL-36

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/2017/050605s050,050672s036lbl.pdf
11/22/2016 SUPPL-35

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050605s049,050672s035lbl.pdf
08/26/2015 SUPPL-34

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s048,050672s034lbl.pdf
06/26/2015 SUPPL-33

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050605s047,050672s033lbl.pdf
09/20/2014 SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf
09/20/2014 SUPPL-29

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf
09/20/2014 SUPPL-29

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050672s029s032lbl.pdf
08/01/2007 SUPPL-28

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050672s028lbl.pdf
06/03/2004 SUPPL-25

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50605slr039,50672slr025_ceftin_lbl.pdf
04/11/2002 SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s33lbl.pdf
03/29/2002 SUPPL-13

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50605s31lbl.pdf
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