FDA.reportPublic FDA data

Application 091427

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2005Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent