Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203502
Company: AUROLIFE PHARMA LLC

• REMS

Products on ANDA 203502

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 203502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2024	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/18/2024	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/18/2024	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/02/2021	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/18/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/18/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/26/2017	SUPPL-3	REMS-Modified		Label is not available on this site.
09/30/2016	SUPPL-2	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/20/2016	SUPPL-1	REMS-Modified		Label is not available on this site.

Therapeutic Equivalents for ANDA 203502

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	090065	EPIC PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AA	088108	ROXANE
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	090065	EPIC PHARMA LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	088109	ROXANE
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	040241	VISTAPHARM LLC
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	204166	VISTAPHARM LLC