FDA Approval for VYALEV issued to ABBVIE INC

10/17/24 1:29:31 PM ET

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New Drug Application (NDA): 216962
Company: ABBVIE INC

Products on NDA 216962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYALEV	FOSCARBIDOPA AND FOSLEVODOPA	12MG/240MG / ML	INJECTION;SOLUTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216962Orig1s000ltr.pdf

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FDA Approval for VYALEV issued to ABBVIE INC

Products on NDA 216962

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216962

Original Approvals or Tentative Approvals

Chat with this insight

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