Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212093
Company: LANNETT CO INC

Products on ANDA 212093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212093

METHADONE HYDROCHLORIDE

CONCENTRATE;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	040180	HIKMA
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	212093	LANNETT CO INC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	207368	SPECGX LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	040088	VISTAPHARM LLC
METHADONE HYDROCHLORIDE INTENSOL	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	089897	HIKMA
METHADOSE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE;ORAL	Prescription	Yes	AA	017116	SPECGX LLC