Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077142
Company: SPECGX LLC
Company: SPECGX 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 |
---|---|---|---|---|---|---|---|
07/12/2005 | 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 |
---|---|---|---|---|---|
09/18/2018 | SUPPL-17 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/13/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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11/05/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/09/2009 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/04/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
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03/23/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/20/2006 | SUPPL-2 | 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 |
METHADOSE | METHADONE HYDROCHLORIDE | 40MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AA | 074184 | SPECGX LLC |