Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088375
Company: MUTUAL PHARM

Products on ANDA 088375

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 088375

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/1983	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
12/03/2010	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/01/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/23/1990	SUPPL-15	Labeling		Label is not available on this site.
08/19/1988	SUPPL-13	Labeling		Label is not available on this site.
06/02/1988	SUPPL-12	Labeling		Label is not available on this site.
03/03/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/31/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/11/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/11/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/11/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/11/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.