Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090635
Company: THEPHARMANETWORK LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
11/25/2009 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-20 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-16 REMS-Modified

Label is not available on this site.

09/30/2016 SUPPL-14 REMS - MODIFIED - D-N-A

Label is not available on this site.

04/20/2016 SUPPL-13 REMS-Modified

Label is not available on this site.

06/04/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/26/2015 SUPPL-10 REMS-Proposal

Label is not available on this site.

08/19/2014 SUPPL-9 REMS-Modified

Label is not available on this site.

07/23/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/15/2013 SUPPL-5 REMS-Modified

Label is not available on this site.

07/09/2012 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/09/2012 SUPPL-3 Labeling-Medication Guide, REMS-Proposal

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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English