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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006383
Company: MALLINCKRODT INC

Products on NDA 006383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	50GM/BOT	POWDER;FOR RX COMPOUNDING	Discontinued	None	No	No
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	100GM/BOT	POWDER;FOR RX COMPOUNDING	Discontinued	None	No	No
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	500GM/BOT	POWDER;FOR RX COMPOUNDING	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/1947	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006383s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/006383Orig1s018ltr.pdf
12/16/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006383s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006383Orig1s017ltr.pdf
06/05/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/22/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/04/1997	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/1993	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/1980	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/10/1977	SUPPL-5	Labeling		Label is not available on this site.

Labels for NDA 006383

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006383s018lbl.pdf
12/16/2016	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006383s017lbl.pdf
12/16/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006383s017lbl.pdf
12/16/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006383s017lbl.pdf

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