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 |
| 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 |