Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090707
Company: VISTAPHARM LLC
Company: VISTAPHARM LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | AA | No | No |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 06/30/2010 | 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-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/02/2021 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2018 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 01/23/2017 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-5 | REMS-Modified |
Label is not available on this site. |
||
| 04/16/2014 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf | |
| 04/15/2013 | SUPPL-2 | REMS-Modified |
Label is not available on this site. |
||
| 11/02/2012 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/16/2014 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf | |
| 04/16/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf |
METHADONE HYDROCHLORIDE
SOLUTION;ORAL; 5MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 087393 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207537 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 090707 | VISTAPHARM LLC |
SOLUTION;ORAL; 10MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 087997 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207537 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 090707 | VISTAPHARM LLC |