Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040180
Company: HIKMA
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
04/30/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40180ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2007 SUPPL-3 Labeling

Label is not available on this site.

10/28/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-1 Manufacturing (CMC)

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 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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