Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210730
Company: TREVENA

Products on NDA 210730

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLINVYK	OLICERIDINE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
OLINVYK	OLICERIDINE	2MG/2ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
OLINVYK	OLICERIDINE	30MG/30ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210730

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
08/07/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – October 30, 2020

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/04/2021	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)

Labels for NDA 210730

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)
03/04/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)
03/04/2021	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)
08/07/2020	ORIG-1	Approval	Label (PDF)