Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075082
Company: VISTAPHARM

Products on ANDA 075082

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 075082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75082ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2018	SUPPL-8	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/17/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/14/2007	SUPPL-5	Labeling		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
08/25/1998	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075082

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