Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070600
Company: CHARTWELL RX

Products on ANDA 070600

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOTHIXENE	THIOTHIXENE	1MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070600

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1987	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
01/22/2025	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
12/12/2024	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/25/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/10/2002	SUPPL-16	Labeling		Label is not available on this site.
11/26/1997	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/20/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/28/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/05/1990	SUPPL-11	Labeling		Label is not available on this site.
01/28/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/04/1991	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/04/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/08/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/25/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.