Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077142
Company: SPECGX LLC

Products on ANDA 077142

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077142

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2005	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-17	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/13/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/05/2014	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/09/2009	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/04/2007	SUPPL-5	Labeling		Label is not available on this site.
03/23/2006	SUPPL-3	Labeling		Label is not available on this site.
09/20/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077142

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