Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 011808
Company: NOVARTIS

Products on NDA 011808

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MELLARIL	THIORIDAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE;ORAL	Discontinued	None	No	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
MELLARIL	THIORIDAZINE HYDROCHLORIDE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011808

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/1962	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2001	SUPPL-179	Manufacturing (CMC)		Label is not available on this site.
03/15/2001	SUPPL-178	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF
06/15/2001	SUPPL-177	Manufacturing (CMC)		Label is not available on this site.
03/01/2000	SUPPL-176	Manufacturing (CMC)		Label is not available on this site.
06/19/2000	SUPPL-175	Labeling		Label is not available on this site.
12/07/2007	SUPPL-174	Labeling		Label is not available on this site.
04/15/1999	SUPPL-173	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/25/1999	SUPPL-172	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/07/2007	SUPPL-171	Labeling		Label is not available on this site.
01/15/1997	SUPPL-170	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/1996	SUPPL-169	Manufacturing (CMC)-Control		Label is not available on this site.
11/22/1995	SUPPL-168	Manufacturing (CMC)		Label is not available on this site.
12/07/2007	SUPPL-166	Labeling		Label is not available on this site.
10/17/1995	SUPPL-165	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/2007	SUPPL-164	Labeling		Label is not available on this site.
12/07/2007	SUPPL-160	Labeling		Label is not available on this site.
12/07/2007	SUPPL-159	Labeling		Label is not available on this site.
12/07/2007	SUPPL-157	Labeling		Label is not available on this site.
12/07/2007	SUPPL-154	Labeling		Label is not available on this site.
12/07/2007	SUPPL-153	Labeling		Label is not available on this site.
12/07/2007	SUPPL-152	Labeling		Label is not available on this site.
12/07/2007	SUPPL-150	Labeling		Label is not available on this site.
12/07/2007	SUPPL-148	Labeling		Label is not available on this site.
12/07/2007	SUPPL-145	Labeling		Label is not available on this site.
12/07/2007	SUPPL-139	Labeling		Label is not available on this site.
12/02/1994	SUPPL-138	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/07/2007	SUPPL-137	Labeling		Label is not available on this site.
12/07/2007	SUPPL-136	Labeling		Label is not available on this site.
12/07/2007	SUPPL-129	Labeling		Label is not available on this site.
12/07/2007	SUPPL-128	Labeling		Label is not available on this site.
12/07/2007	SUPPL-126	Labeling		Label is not available on this site.
12/07/2007	SUPPL-118	Labeling		Label is not available on this site.
11/28/1994	SUPPL-117	Manufacturing (CMC)-Control		Label is not available on this site.
12/07/2007	SUPPL-107	Labeling		Label is not available on this site.
12/07/2007	SUPPL-106	Labeling		Label is not available on this site.
12/07/2007	SUPPL-105	Labeling		Label is not available on this site.
12/07/2007	SUPPL-101	Labeling		Label is not available on this site.
12/07/2007	SUPPL-97	Labeling		Label is not available on this site.
12/07/2007	SUPPL-96	Labeling		Label is not available on this site.
12/07/2007	SUPPL-93	Labeling		Label is not available on this site.
12/07/2007	SUPPL-85	Labeling		Label is not available on this site.
12/07/2007	SUPPL-77	Labeling		Label is not available on this site.
12/07/2007	SUPPL-68	Labeling		Label is not available on this site.
12/07/2007	SUPPL-61	Labeling		Label is not available on this site.
12/07/2007	SUPPL-59	Labeling		Label is not available on this site.
12/07/2007	SUPPL-31	Efficacy		Label is not available on this site.
12/07/2007	SUPPL-29	Labeling		Label is not available on this site.
12/07/2007	SUPPL-28	Labeling		Label is not available on this site.