Application 040642

Type
ANDA
Sponsor
BRECKENRIDGE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHSCOPOLAMINE BROMIDEMETHSCOPOLAMINE BROMIDETABLET;ORAL2.5MGNoNo
002METHSCOPOLAMINE BROMIDEMETHSCOPOLAMINE BROMIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-191Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-191Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-191Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-192Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-192Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-192Methscopolamine Bromidemethscopolamine bromideBreckenridge Pharmaceutical, Inc.ANDACurrent