Drugs@FDA: FDA-Approved Drugs
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. |
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12/15/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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11/23/2022 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/23/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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11/23/2022 | SUPPL-26 | Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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11/23/2022 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/26/2017 | SUPPL-24 | REMS-Modified |
Label is not available on this site. |
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09/30/2016 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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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. |
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08/19/2014 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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07/23/2014 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/15/2013 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
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07/09/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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07/09/2012 | SUPPL-12 | REMS-Proposal |
Label is not available on this site. |
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01/10/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/14/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/02/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/24/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |