FDA.reportPublic FDA data

Application 204386

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRETYLIUM TOSYLATEBRETYLIUM TOSYLATEINJECTABLE;INJECTION50MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61916-135Bretylium TosylateBretylium TosylatePharmaceutics International, Inc. (Pii)ANDACurrent
62559-870Bretylium Tosylatebretylium tosylateANI Pharmaceuticals, Inc.ANDACurrent
62559-870Bretylium Tosylatebretylium tosylateANI Pharmaceuticals, Inc.ANDACurrent