Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211228
Company: ASCENT PHARMS INC

• REMS

Products on ANDA 211228

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/03/2019	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-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-6	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/22/2025	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/02/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/19/2021	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 211228

METHADONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	211228	ASCENT PHARMS INC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	203502	AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	210484	ELITE LABS INC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	090065	EPIC PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	088109	HIKMA
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	040517	SPECGX LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	090635	THEPHARMANETWORK LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	211228	ASCENT PHARMS INC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	203502	AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	210484	ELITE LABS INC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	090065	EPIC PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	088109	HIKMA
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040517	SPECGX LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	090635	THEPHARMANETWORK LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	204166	VISTAPHARM LLC