Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071554
Company: TEVA PHARMS

Products on ANDA 071554

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTHIXENE HYDROCHLORIDE	THIOTHIXENE HYDROCHLORIDE	EQ 5MG BASE/ML	CONCENTRATE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/1987	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
09/11/2002	SUPPL-16	Labeling		Label is not available on this site.
10/31/2001	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2002	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
02/26/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
06/17/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/23/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/11/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/17/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/17/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/07/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/14/1990	SUPPL-1	Labeling		Label is not available on this site.