Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090707
Company: VISTAPHARM
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
06/30/2010 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
10/11/2019 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/21/2018 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-17 REMS - MODIFIED - D-N-A

Label is not available on this site.

02/01/2018 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/31/2018 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/26/2017 SUPPL-13 REMS-Modified

Label is not available on this site.

01/23/2017 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-7 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-6 REMS - MODIFIED - D-N-A

Label is not available on this site.

08/19/2014 SUPPL-5 REMS-Modified

Label is not available on this site.

04/16/2014 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf
04/15/2013 SUPPL-2 REMS-Modified

Label is not available on this site.

11/02/2012 SUPPL-1 REMS-Proposal

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2014 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf
04/16/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090707Orig1s003lbl.pdf

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 087393 HIKMA
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

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 087997 HIKMA
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

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