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Drugs@FDA: FDA-Approved Drugs

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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BUSPAR BUSPIRONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
BUSPAR BUSPIRONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
BUSPAR BUSPIRONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
BUSPAR BUSPIRONE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
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