Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040050
Company: SPECGX LLC

• Other Important Information from FDA

• REMS

Products on ANDA 040050

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADOSE	METHADONE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
METHADOSE	METHADONE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040050

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/1993	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
12/23/2025	SUPPL-34	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-33	REMS-Modified		Label is not available on this site.
06/24/2025	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
11/23/2022	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/23/2022	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-27	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/23/2022	SUPPL-26	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/23/2022	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/26/2017	SUPPL-24	REMS-Modified		Label is not available on this site.
09/30/2016	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/20/2016	SUPPL-21	REMS-Modified		Label is not available on this site.
06/01/2015	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/26/2015	SUPPL-19	REMS-Modified		Label is not available on this site.
08/19/2014	SUPPL-18	REMS-Modified		Label is not available on this site.
07/23/2014	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/15/2013	SUPPL-14	REMS-Modified		Label is not available on this site.
07/09/2012	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/09/2012	SUPPL-12	REMS-Proposal		Label is not available on this site.
01/10/2007	SUPPL-10	Labeling		Label is not available on this site.
11/14/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/02/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/24/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/29/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.