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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074184
Company: SPECGX LLC

Other Important Information from FDA

Products on ANDA 074184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHADOSE	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1993	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-22	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/13/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/09/2009	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/04/2007	SUPPL-11	Labeling		Label is not available on this site.
03/23/2006	SUPPL-10	Labeling		Label is not available on this site.
11/28/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
11/21/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/29/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074184

METHADOSE

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

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