CYCLOSET از شرکت VEROSCIENCE

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): 020866

Company: VEROSCIENCE

Summary Review

Products on NDA 020866

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSET	BROMOCRIPTINE MESYLATE	EQ 0.8MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020866

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2009	ORIG-1	Approval	Type 3 – New Dosage Form	STANDARD	Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866Orig1s000SumR.pdf

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

05/05/2009

ORIG-1

Approval

Type 3 – New Dosage Form

STANDARD

Review

Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020866Orig1s013ltr.pdf
08/17/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020866Orig1s012ltr.pdf
02/02/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020866Orig1s009ltr.pdf
10/20/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020866Orig1s008ltr.pdf
02/06/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf
02/06/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020866Orig1s006,s007ltr.pdf
03/14/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/12/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/24/2011	SUPPL-2	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020866s002ltr.pdf

Labels for NDA 020866

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
08/17/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s012lbl.pdf
04/03/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020866s013lbl.pdf
02/06/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf
02/06/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020866s006s007lbl.pdf
02/02/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020866s009lbl.pdf
10/20/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020866s008lbl.pdf
03/24/2011	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf
03/24/2011	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf
03/24/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020866s002lbl.pdf

منبع : www.accessdata.fda.gov

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