Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207537
Company: PHARM ASSOC
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.

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 No AA 207537 PHARM ASSOC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 090707 VISTAPHARM
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 087393 WEST-WARD PHARMS INT

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 No AA 207537 PHARM ASSOC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 090707 VISTAPHARM
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG/5ML SOLUTION;ORAL Prescription No AA 087997 WEST-WARD PHARMS INT

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