FDA.reportPublic FDA data

Application 209293

Type
ANDA
Sponsor
SCIECURE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo
003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 37.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-703PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-703PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-703PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-705PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-705PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-705PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-707PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-707PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
42858-707PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATERhodes Pharmaceuticals L.P.ANDACurrent
63629-9498PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATEBryant Ranch PrepackANDACurrent
63629-9499PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATEBryant Ranch PrepackANDACurrent
63629-9500PAROXETINEPAROXETINE HYDROCHLORIDE HEMIHYDRATEBryant Ranch PrepackANDACurrent