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

New Drug Application (NDA): 050823

Company: B BRAUN

Summary Review

Products on NDA 050823

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050823

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

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.

Labels for NDA 050823

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

حتما بخوانید : CEFTAZIDIME از شرکت ACS DOBFAR

منبع : www.accessdata.fda.gov

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CEFTAZIDIME IN DEXTROSE CONTAINER از شرکت B BRAUN