Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075082
Company: VISTAPHARM
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
03/25/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75082ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/17/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/14/2007 SUPPL-5 Labeling

Label is not available on this site.

02/02/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/25/1998 SUPPL-1 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

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