Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088736
Company: HERITAGE PHARMA AVET

Products on ANDA 088736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/1984	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
02/23/2017	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/03/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/09/1990	SUPPL-9	Labeling		Label is not available on this site.
01/28/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/21/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/21/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/21/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.