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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040241
Company: VISTAPHARM LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;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
05/29/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40241ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-19 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-18 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-16 REMS - MODIFIED - D-N-A

Label is not available on this site.
10/31/2016 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
04/20/2016 SUPPL-14 REMS-Modified

Label is not available on this site.
05/29/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
06/26/2015 SUPPL-12 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-11 REMS-Modified

Label is not available on this site.
12/19/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
04/15/2013 SUPPL-8 REMS-Modified

Label is not available on this site.
07/09/2012 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
07/09/2012 SUPPL-6 REMS-Proposal

Label is not available on this site.
02/05/2007 SUPPL-4 Labeling

Label is not available on this site.
02/02/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

METHADONE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 088109 ROXANE
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090635 THEPHARMANETWORK LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040241 VISTAPHARM LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 204166 VISTAPHARM LLC
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