Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AA | No | Yes |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/27/2004 | 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 |
---|---|---|---|---|---|
01/03/2024 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/03/2024 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/31/2023 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/02/2021 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/16/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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03/16/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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03/16/2022 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/16/2022 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/26/2017 | SUPPL-22 | REMS-Modified |
Label is not available on this site. |
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09/30/2016 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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10/28/2016 | SUPPL-19 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/20/2016 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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06/01/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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06/26/2015 | SUPPL-15 | REMS-Modified |
Label is not available on this site. |
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08/19/2014 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
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07/23/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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04/15/2013 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
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07/09/2012 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/09/2012 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |
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01/26/2008 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/10/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/02/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 211228 | ASCENT PHARMS INC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 203502 | AUROLIFE PHARMA LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 090065 | EPIC PHARMA LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 088108 | ROXANE |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 040517 | SPECGX LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AA | 090635 | THEPHARMANETWORK LLC |
TABLET;ORAL; 10MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 211228 | ASCENT PHARMS INC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 203502 | AUROLIFE PHARMA LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 090065 | EPIC PHARMA LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 088109 | ROXANE |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 040517 | SPECGX LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 090635 | THEPHARMANETWORK LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 040241 | VISTAPHARM LLC |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 204166 | VISTAPHARM LLC |