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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207368
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-Container/Carton Labels, Labeling-Package Insert

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
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
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