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
BENTYL از شرکت APTALIS PHARMA US
New Drug Application (NDA): 007961
Company: APTALIS PHARMA US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 04/30/1951 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 08/01/2011 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf |
||
| 02/02/2007 | SUPPL-26 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf |
||
| 08/17/1999 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/09/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/25/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/04/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/12/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2011 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf | |
| 02/02/2007 | SUPPL-26 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |
نظرات کاربران