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
BUTISOL SODIUM از شرکت MYLAN SPECIALITY LP
New Drug Application (NDA): 000793
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTISOL SODIUM | BUTABARBITAL SODIUM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
No | No |
| BUTISOL SODIUM | BUTABARBITAL SODIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
No | No |
| BUTISOL SODIUM | BUTABARBITAL SODIUM | 30MG | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BUTISOL SODIUM | BUTABARBITAL SODIUM | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 06/05/1939 | ORIG-1 | Approval |
UNKNOWN |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/06/2019 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/000793s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/000793Orig1s026ltr.pdf |
||
| 09/28/2007 | SUPPL-25 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/000793s025ltr.pdf |
||
| 10/23/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1987 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1986 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/29/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1982 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/26/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/16/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/02/1978 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/1976 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/06/2019 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/000793s026lbl.pdf | |
| 09/28/2007 | SUPPL-25 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/000793s025lbl.pdf |
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