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. |
||
| 01/03/2024 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2023 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2021 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-22 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/28/2016 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
||
| 06/01/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-15 | REMS-Modified |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-14 | REMS-Modified |
Label is not available on this site. |
||
| 07/23/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |
||
| 01/26/2008 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 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 |