CEFTAZIDIME IN DEXTROSE CONTAINER از شرکت B BRAUN

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

CEFTAZIDIME IN DEXTROSE CONTAINER از شرکت B BRAUN

New Drug Application (NDA): 050823

Company: B BRAUN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTAZIDIME IN DEXTROSE CONTAINER CEFTAZIDIME EQ 1GM BASE INJECTABLE;INJECTION Prescription

None

Yes No
CEFTAZIDIME IN DEXTROSE CONTAINER CEFTAZIDIME EQ 2GM BASE INJECTABLE;INJECTION Prescription

None

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/13/2011 ORIG-1 Approval

Type 5 – New Formulation or New Manufacturer

STANDARD

Letter (PDF)

Review

Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050823s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823_ceftazidime_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050823Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2021 SUPPL-9 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050823s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050823Orig1s009ltr.pdf

07/29/2019 SUPPL-7 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050823Orig1s007ltr.pdf

05/15/2015 SUPPL-4 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/2015/050823s004lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050823Orig1s004ltr.pdf

04/01/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2021 SUPPL-9

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050823s009lbl.pdf
07/29/2019 SUPPL-7

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf
05/15/2015 SUPPL-4

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/2015/050823s004lbl.pdf
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