Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090635
Company: THEPHARMANETWORK LLC
Company: THEPHARMANETWORK LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AA | No | No |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 11/25/2009 | 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 |
|---|---|---|---|---|---|
| 03/08/2024 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/08/2024 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2023 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2019 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2019 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 07/16/2019 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 06/04/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-10 | REMS-Proposal |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
| 07/23/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-3 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
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 |
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 |