Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018513
Company: LEADIANT BIOSCI INC
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CHENIX CHENODIOL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
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.

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