Drugs@FDA: FDA-Approved Drugs
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BUSPAR | BUSPIRONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
BUSPAR | BUSPIRONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
BUSPAR | BUSPIRONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
BUSPAR | BUSPIRONE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
Review (PDF)
|
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf |
05/03/2001 | SUPPL-45 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf | |
07/19/2001 | SUPPL-43 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
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 |
Label (PDF)
|
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 |