Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205525
Company: BENUVIA OPERATIONS

Products on NDA 205525

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYNDROS	DRONABINOL	5MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205525

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
07/01/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – March 23, 2017

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/21/2022	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)
03/22/2021	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
09/14/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)
04/12/2018	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
05/25/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)
12/08/2016	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for NDA 205525

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/21/2022	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)
09/21/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)
03/22/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)
03/22/2021	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)
09/14/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)
05/25/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)
07/01/2016	ORIG-1	Approval	Label (PDF)