Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040241
Company: VISTAPHARM LLC

• REMS

Products on ANDA 040241

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040241

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40241ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2025	SUPPL-29	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-28	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/22/2025	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-19	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/26/2017	SUPPL-18	REMS-Modified		Label is not available on this site.
09/30/2016	SUPPL-16	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/31/2016	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/20/2016	SUPPL-14	REMS-Modified		Label is not available on this site.
05/29/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/26/2015	SUPPL-12	REMS-Modified		Label is not available on this site.
08/19/2014	SUPPL-11	REMS-Modified		Label is not available on this site.
12/19/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
04/15/2013	SUPPL-8	REMS-Modified		Label is not available on this site.
07/09/2012	SUPPL-7	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/09/2012	SUPPL-6	REMS-Proposal		Label is not available on this site.
02/05/2007	SUPPL-4	Labeling		Label is not available on this site.
02/02/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.