FDA.reportPublic FDA data

Application 083711

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5319Promethazine HydrochloridePromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-5319Promethazine HydrochloridePromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent