FDA.reportPublic FDA data

Application 019471

Type
NDA
Sponsor
BIOVAIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDIZEM SRDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CARDIZEM SRDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CARDIZEM SRDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004CARDIZEM SRDILTIAZEM HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo