FDA.reportPublic FDA data

Application 040442

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBINOXAMINE MALEATECARBINOXAMINE MALEATETABLET;ORAL4MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-191carbinoxamine maleatecarbinoxamine maleateMikart, Inc.ANDACurrent
46672-191carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-191carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-191carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-191carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
51991-333Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-333Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-333Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-333Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent