CYANOKIT از شرکت SERB SA

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): 022041

Company: SERB SA

Products on NDA 022041

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYANOKIT	HYDROXOCOBALAMIN	5GM/VIAL (5GM/KIT)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
CYANOKIT	HYDROXOCOBALAMIN	2.5GM/VIAL (5GM/KIT)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022041

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2006	ORIG-1	Approval	Type 3 – New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022041s000_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022041_cyanokit_toc.cfm

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

12/15/2006

ORIG-1

Approval

Type 3 – New Dosage Form

PRIORITY; Orphan

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022041s000_LTR.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022041_cyanokit_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2018	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022041Orig1s019, s020ltr.pdf
12/31/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022041Orig1s019, s020ltr.pdf
02/04/2016	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/03/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/21/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/08/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf
04/08/2011	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf
02/19/2010	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s007ltr.pdf
06/04/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022041s005ltr.pdf
10/13/2010	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s004ltr.pdf
02/04/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022041

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
12/31/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf
12/31/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022041s019, 020lbl.pdf
04/08/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf
04/08/2011	SUPPL-8	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf
10/13/2010	SUPPL-4	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s004lbl.pdf
02/19/2010	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf
06/04/2009	SUPPL-5	Labeling	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf
12/15/2006	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf

منبع : www.accessdata.fda.gov

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CYANOKIT از شرکت SERB SA