COTEMPLA XR-ODT از شرکت NEOS THERAPS INC

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
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New Drug Application (NDA): 205489

Company: NEOS THERAPS INC

Medication Guide

Products on NDA 205489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COTEMPLA XR-ODT	METHYLPHENIDATE	8.6MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
COTEMPLA XR-ODT	METHYLPHENIDATE	17.3MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
COTEMPLA XR-ODT	METHYLPHENIDATE	25.9MG	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2017	ORIG-1	Approval	Type 3 – New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.cfm

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

06/19/2017

ORIG-1

Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205489Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205489Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205489Orig1s007ltr.pdf

Action Date

Submission

Supplement Categories or Approval Type

Letters, Reviews, Labels, Patient Package Insert

Note

Url

06/25/2021

SUPPL-7

Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205489Orig1s007ltr.pdf

Labels for NDA 205489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf
06/19/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf

منبع : www.accessdata.fda.gov

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COTEMPLA XR-ODT از شرکت NEOS THERAPS INC