Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088136
Company: CHARTWELL RX

Products on ANDA 088136

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	150MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1986	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
01/22/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/19/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/16/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2002	SUPPL-14	Labeling		Label is not available on this site.
02/21/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2001	SUPPL-12	Labeling		Label is not available on this site.
05/05/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/21/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/09/1990	SUPPL-8	Labeling		Label is not available on this site.
09/28/1989	SUPPL-7	Labeling		Label is not available on this site.
11/10/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/09/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/09/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/09/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.