Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040517
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AA 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
04/27/2004 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-25 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-22 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-20 REMS - MODIFIED - D-N-A

Label is not available on this site.

10/28/2016 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-18 REMS-Modified

Label is not available on this site.

06/01/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/26/2015 SUPPL-15 REMS-Modified

Label is not available on this site.

08/19/2014 SUPPL-14 REMS-Modified

Label is not available on this site.

07/23/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-9 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/09/2012 SUPPL-7 REMS-Proposal

Label is not available on this site.

01/26/2008 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/2007 SUPPL-3 Labeling

Label is not available on this site.

03/02/2006 SUPPL-2 Labeling

Label is not available on this site.

METHADONE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 211228 ASCENT PHARMS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 203502 AUROLIFE PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
METHADOSE METHADONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

TABLET;ORAL; 10MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AA 006134 WEST-WARD PHARMS INT
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 210484 ELITE LABS INC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 090065 EPIC PHARMA LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040517 SPECGX LLC
METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 208305 SUN PHARM INDUSTRIES
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
METHADOSE METHADONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AA 040050 SPECGX LLC

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