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): 008370
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/13/1952 | 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 |
|---|---|---|---|---|---|
| 01/11/2013 | SUPPL-33 | 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-32 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf |
||
| 02/02/2007 | SUPPL-31 | 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 |
||
| 08/12/2002 | SUPPL-30 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08-370slr030ltr.pdf |
|
| 06/23/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/06/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/23/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1990 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 01/04/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | 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-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1984 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-13 | 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-33 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007409s042,008370s033lbl.pdf | |
| 08/01/2011 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf | |
| 02/02/2007 | SUPPL-31 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf |
BENTYL
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008370 | ALLERGAN |
| BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008370 | ALLERGAN |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207084 | AKORN |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208353 | AM REGENT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210788 | CUSTOPHARM INC |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210979 | FOSUN PHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210257 | FRESENIUS KABI USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212058 | GENE YORK PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206468 | NEXUS PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207076 | SLATE |
| DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040465 | WEST-WARD PHARMS INT |
BENTYL PRESERVATIVE FREE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENTYL | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008370 | ALLERGAN |
| BENTYL PRESERVATIVE FREE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 008370 | ALLERGAN |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207084 | AKORN |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208353 | AM REGENT |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210788 | CUSTOPHARM INC |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210979 | FOSUN PHARMA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210257 | FRESENIUS KABI USA |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212058 | GENE YORK PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206468 | NEXUS PHARMS |
| DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207076 | SLATE |
| DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) | DICYCLOMINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040465 | WEST-WARD PHARMS INT |
نظرات کاربران