Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207537
Company: SPECGX LLC
Company: SPECGX 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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/02/2019 | 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 |
---|---|---|---|---|---|
01/03/2024 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/03/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/04/2021 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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02/08/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
METHADONE HYDROCHLORIDE
SOLUTION;ORAL; 5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 087393 | HIKMA |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207537 | SPECGX LLC |
SOLUTION;ORAL; 10MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 087997 | HIKMA |
METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207537 | SPECGX LLC |