FDA.reportPublic FDA data

Application 206891

Type
ANDA
Sponsor
ACELLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATESOLUTION;ORAL4MG/5ML;5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42192-612Hydrocodone Bitartrate and Chlorpheniramine MaleateHydrocodone Bitartrate and Chlorpheniramine MaleateAcella Pharmaceuticals, LLCANDACurrent
42192-612Hydrocodone Bitartrate and Chlorpheniramine MaleateHydrocodone Bitartrate and Chlorpheniramine MaleateAcella Pharmaceuticals, LLCANDACurrent
42192-612Hydrocodone Bitartrate and Chlorpheniramine MaleateHydrocodone Bitartrate and Chlorpheniramine MaleateAcella Pharmaceuticals, LLCANDACurrent