Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040088
Company: VISTAPHARM LLC
Company: VISTAPHARM LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 11/30/1994 | 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 |
|---|---|---|---|---|---|
| 01/30/2025 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/18/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2022 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2022 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2022 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2011 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/27/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
CONCENTRATE;ORAL; 10MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 040180 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 212093 | LANNETT CO INC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 207368 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 040088 | VISTAPHARM LLC |
| METHADONE HYDROCHLORIDE INTENSOL | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | No | AA | 089897 | HIKMA |
| METHADOSE | METHADONE HYDROCHLORIDE | 10MG/ML | CONCENTRATE;ORAL | Prescription | Yes | AA | 017116 | SPECGX LLC |