Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018513
Company: LEADIANT BIOSCI INC
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CHENIX | CHENODIOL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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. |
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11/16/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/22/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/24/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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04/17/1984 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/18/1984 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/25/1986 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/25/1986 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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04/17/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |