Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088131
Company: CHARTWELL RX

Products on ANDA 088131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1983	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-47	Labeling-Package Insert		Label is not available on this site.
04/19/2016	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
12/16/2002	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2002	SUPPL-41	Labeling		Label is not available on this site.
02/21/2001	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2001	SUPPL-39	Labeling		Label is not available on this site.
05/05/1999	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
09/18/1998	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
10/20/1998	SUPPL-35	Labeling		Label is not available on this site.
10/20/1998	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
03/21/1995	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
01/02/1990	SUPPL-32	Labeling		Label is not available on this site.
09/28/1989	SUPPL-31	Labeling		Label is not available on this site.
11/10/1988	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
03/18/1987	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
04/18/1986	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/03/1986	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/13/1986	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/13/1986	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/13/1986	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/18/1986	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/23/1984	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/23/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/23/1984	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/23/1984	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/23/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/28/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.