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
BUSPAR از شرکت BRISTOL MYERS SQUIBB
New Drug Application (NDA): 018731
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUSPAR | BUSPIRONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BUSPAR | BUSPIRONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BUSPAR | BUSPIRONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BUSPAR | BUSPIRONE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 09/29/1986 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018731Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/22/2010 | SUPPL-51 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf |
||
| 09/21/2007 | SUPPL-48 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf |
||
| 02/07/2002 | SUPPL-46 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf |
|
| 05/03/2001 | SUPPL-45 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf |
||
| 07/19/2001 | SUPPL-43 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf |
||
| 04/25/2000 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/01/1999 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1999 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/03/2001 | SUPPL-39 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf |
||
| 01/27/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 12/30/1996 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/22/1996 | SUPPL-31 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 06/19/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1996 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 04/22/1996 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/05/1990 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/26/1990 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/28/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1988 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/23/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1987 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/25/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/25/1989 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1986 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/16/1986 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/22/2010 | SUPPL-51 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf | |
| 09/21/2007 | SUPPL-48 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf | |
| 07/19/2001 | SUPPL-43 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf | |
| 05/03/2001 | SUPPL-45 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf | |
| 05/03/2001 | SUPPL-39 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf |
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