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
CEPHULAC از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 017657
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHULAC | LACTULOSE | 10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION;ORAL, RECTAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 03/25/1976 | 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 |
|---|---|---|---|---|---|
| 02/09/1993 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1991 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1988 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1987 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/27/1988 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1988 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/09/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1983 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/22/1981 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/13/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/03/1980 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/20/1980 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/20/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/04/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/27/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1978 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/04/1979 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/08/1977 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/03/1977 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/12/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/12/1977 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1980 | SUPPL-1 | Efficacy |
Label is not available on this site. |
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