Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207368
Company: SPECGX LLC
Company: SPECGX 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 |
---|---|---|---|---|---|---|---|
08/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/18/2021 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |