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
BREVITAL SODIUM از شرکت PAR STERILE PRODUCTS
New Drug Application (NDA): 011559
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 500MG/VIAL | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 2.5GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 5GM/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BREVITAL SODIUM | METHOHEXITAL SODIUM | 200MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/27/1960 | 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 |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-57 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/011559s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/011559Orig1s057ltr.pdf |
||
| 04/27/2017 | SUPPL-51 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011559Orig1s051ltr.pdf |
||
| 12/15/2014 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2014 | SUPPL-45 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011559Orig1s045ltr.pdf |
||
| 05/05/2008 | SUPPL-41 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/011559s041ltr.pdf |
||
| 05/27/2004 | SUPPL-37 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11559slr037ltr.pdf |
||
| 03/14/2003 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11559scm033ltr.pdf |
|
| 07/13/2001 | SUPPL-32 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11559s32ltr.pdf |
|
| 12/17/1997 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-29 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-28 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 07/25/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/29/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1994 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/18/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/01/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/13/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/11/1969 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-57 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/011559s057lbl.pdf | |
| 04/27/2017 | SUPPL-51 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011559s051lbl.pdf | |
| 01/23/2014 | SUPPL-45 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011559s045lbl.pdf | |
| 05/05/2008 | SUPPL-41 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/011559s041lbl.pdf | |
| 05/27/2004 | SUPPL-37 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11559slr037_brevital_lbl.pdf |
نظرات کاربران