Drugs@FDA: FDA-Approved Drugs

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New Drug Application:
Company:

Products on 205581

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS

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

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.