اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHENIX از شرکت LEADIANT BIOSCI INC
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| CHENIX | CHENODIOL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
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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