Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219647
Company: NOVITIUM PHARMA

Products on ANDA 219647

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	5MG/ML	SOLUTION;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219647

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.