Application 021726

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIRAVAMALPRAZOLAMTABLET, ORALLY DISINTEGRATING;ORAL0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002NIRAVAMALPRAZOLAMTABLET, ORALLY DISINTEGRATING;ORAL0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003NIRAVAMALPRAZOLAMTABLET, ORALLY DISINTEGRATING;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004NIRAVAMALPRAZOLAMTABLET, ORALLY DISINTEGRATING;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
6059SUPPL2011-06-24
16264SUPPL2011-06-16
42285ORIG2006-07-25
28473SUPPL2006-02-07
16263SUPPL2006-02-07
28472ORIG2005-01-26
16262ORIG2005-01-26