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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208944
Company: ADAMAS OPERATIONS

Products on NDA 208944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
GOCOVRI	AMANTADINE HYDROCHLORIDE	EQ 137MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208944Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208944Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2021	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208944s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208944Orig1s004ltr.pdf
03/10/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208944s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208944Orig1s003ltr.pdf

Labels for NDA 208944

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2021	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208944s004lbl.pdf
03/10/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208944s003lbl.pdf
08/24/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf

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