Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018513
Company: LEADIANT BIOSCI INC

Products on NDA 018513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHENIX	CHENODIOL	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1983	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2010	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018513s012ltr.pdf
01/03/1990	SUPPL-11	Labeling		Label is not available on this site.
11/16/1988	SUPPL-10	Labeling		Label is not available on this site.
12/22/1986	SUPPL-9	Labeling		Label is not available on this site.
04/24/1986	SUPPL-8	Labeling		Label is not available on this site.
04/17/1984	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/18/1984	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/25/1986	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/25/1986	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/17/1984	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.