Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088108
Company: ROXANE

• REMS

Products on ANDA 088108

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088108

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/1983	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
12/15/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/02/2021	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
05/05/2020	SUPPL-21	REMS-Proposal		Label is not available on this site.
04/01/1998	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/01/1998	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/27/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/25/1995	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/19/1995	SUPPL-14	Labeling		Label is not available on this site.
04/01/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/01/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/12/1992	SUPPL-11	Labeling		Label is not available on this site.
02/06/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/31/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/31/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/26/1990	SUPPL-7	Labeling		Label is not available on this site.
07/01/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/01/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088108

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