FDA.reportPublic FDA data

Application 040458

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBINOXAMINE MALEATECARBINOXAMINE MALEATESOLUTION;ORAL4MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, Inc.ANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
46672-644carbinoxamine maleatecarbinoxamine maleateMikart, LLCANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-334Carbinoxamine Maleatecarbinoxamine maleateBreckenridge Pharmaceutical, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22147ORIG2006-04-20