FDA.reportPublic FDA data

Application 022556

Type
NDA
Sponsor
AYTU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KARBINAL ERCARBINOXAMINE MALEATESUSPENSION, EXTENDED RELEASE;ORAL4MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23594-101KarbinalCarbinoxamine MaleateZylera Pharmaceuticals, LNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateCerecor, Inc.NDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent
23594-101KarbinalCarbinoxamine MaleateAytu Therapeutics, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85329SUPPL 2026-03-12
85328SUPPL 2026-03-12
66889SUPPL2021-03-26
66884SUPPL2021-03-26
24339ORIG2014-06-24
22055ORIG2014-06-24
17704ORIG2013-04-01
7528ORIG2013-04-01
52408ORIG1900-01-01
52407ORIG1900-01-01