Application 018731

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSPARBUSPIRONE HYDROCHLORIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002BUSPARBUSPIRONE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003BUSPARBUSPIRONE HYDROCHLORIDETABLET;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004BUSPARBUSPIRONE HYDROCHLORIDETABLET;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57619ORIG2019-02-15
1055SUPPL2010-11-30
11309SUPPL2010-11-22
33583SUPPL2007-09-26
16016SUPPL2007-09-25
20153SUPPL2004-04-14
33582SUPPL2003-04-14
11307SUPPL2003-04-14
1054SUPPL2002-02-07
16015SUPPL2001-07-19
11308SUPPL2001-07-19