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Drugs@FDA: FDA-Approved Drugs

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

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

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
12/15/2023 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-Medication Guide, Labeling-Patient Package Insert

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-Medication Guide, Labeling-Package Insert

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-Package Insert, Labeling-Medication Guide

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.
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