Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074184
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADOSE 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
04/29/1993 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-22 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/13/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

11/09/2009 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/04/2007 SUPPL-11 Labeling

Label is not available on this site.

03/23/2006 SUPPL-10 Labeling

Label is not available on this site.

11/28/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

11/21/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METHADOSE

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

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