Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088137
Company: CHARTWELL RX

Products on ANDA 088137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIORIDAZINE HYDROCHLORIDE	THIORIDAZINE HYDROCHLORIDE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088137

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
02/23/2017	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/22/2016	SUPPL-20	Labeling		Label is not available on this site.
12/16/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2002	SUPPL-15	Labeling		Label is not available on this site.
02/21/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2001	SUPPL-13	Labeling		Label is not available on this site.
05/05/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/21/1995	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/02/1992	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.