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
CANTIL از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 010679
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANTIL | MEPENZOLATE BROMIDE | 25MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| CANTIL | MEPENZOLATE BROMIDE | 25MG/5ML | SOLUTION;ORAL | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 11/14/1956 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/25/2004 | SUPPL-29 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10679slr029ltr.pdf |
||
| 01/29/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1985 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/09/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/04/1980 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/09/1982 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/20/1980 | SUPPL-17 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/25/2004 | SUPPL-29 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/10679slr029_cantil_lbl.pdf |
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