Application 007638

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLOR-TRIMETONCHLORPHENIRAMINE MALEATETABLET, EXTENDED RELEASE;ORAL8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CHLOR-TRIMETONCHLORPHENIRAMINE MALEATETABLET, EXTENDED RELEASE;ORAL12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
135SUPPL2015-12-29
40SUPPL2008-02-07
39SUPPL2006-01-30