Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207537
Company: SPECGX LLC

• REMS

Products on ANDA 207537

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2019	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
12/22/2025	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-11	REMS-Modified		Label is not available on this site.
12/22/2025	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2024	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/03/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/02/2021	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/08/2021	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 207537

METHADONE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	087393	HIKMA
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207537	SPECGX LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	090707	VISTAPHARM LLC

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	087997	HIKMA
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207537	SPECGX LLC