Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075082
Company: VISTAPHARM LLC
Company: VISTAPHARM LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 03/25/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75082ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/27/2024 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2024 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/2024 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-8 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/27/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/17/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/25/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
TABLET, FOR SUSPENSION;ORAL; 40MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AA | 017058 | HIKMA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AA | 077142 | SPECGX LLC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AA | 075082 | VISTAPHARM LLC |
| METHADOSE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AA | 074184 | SPECGX LLC |