FDA.reportPublic FDA data

Application 214238

Type
ANDA
Sponsor
QUAGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateATLANTIC BIOLOGICALS CORP.ANDACurrent
70752-139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateQUAGEN PHARMACEUTICALS LLCANDACurrent
70752-139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine PhosphateQUAGEN PHARMACEUTICALS LLCANDACurrent