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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040180
Company: HIKMA

Products on ANDA 040180

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 040180

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40180ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/31/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/25/2007	SUPPL-3	Labeling		Label is not available on this site.
10/28/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/28/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 040180

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

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