FDA.reportPublic FDA data

Application 040902

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL5MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-679Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine and PhenylephrineAmneal Pharmaceuticals LLCANDACurrent
65162-679Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine and PhenylephrineAmneal Pharmaceuticals LLCANDACurrent
65162-679Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine and PhenylephrineAmneal Pharmaceuticals LLCANDACurrent
65162-679Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine and PhenylephrineAmneal Pharmaceuticals of New York, LLCANDACurrent