Drugs@FDA: FDA-Approved Drugs

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

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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