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 ALLERGAN
New Drug Application (NDA): 007409
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 05/11/1950 | 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 |
|---|---|---|---|---|---|
| 01/11/2013 | SUPPL-42 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007409Orig1s042,008370Orig1s033ltr.pdf |
||
| 08/01/2011 | SUPPL-41 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf |
||
| 02/02/2007 | SUPPL-40 | 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-39 | Labeling |
Label is not available on this site. |
||
| 09/09/1996 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 10/29/1991 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/24/1992 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/25/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/04/1993 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1989 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1990 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/12/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/28/1987 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/11/2013 | SUPPL-42 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf | |
| 08/01/2011 | SUPPL-41 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf | |
| 02/02/2007 | SUPPL-40 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |
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