FDA.reportPublic FDA data

Application 040891

Type
ANDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESYRUP;ORAL6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63187-858PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LPANDACurrent
63187-858PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LPANDACurrent
63629-9151PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-9151PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
68151-0146PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDECarilion Materials ManagementANDACurrent
70408-146PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENostrum Laboratories, Inc.ANDACurrent
70408-146PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENostrum Laboratories, Inc.ANDACurrent