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 |
---|---|---|---|---|---|
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. |
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10/21/2011 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/13/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/27/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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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 |