FDA.report

Application 078902

Type
ANDA
Sponsor
MYLAN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo
003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7001Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7001Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7001Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7001Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7002Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7002Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7002Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7002Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7003Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7003Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7003Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7003Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7004Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7004Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7004Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
0378-7004Paroxetineparoxetine hydrochloride hemihydrateMylan Pharmaceuticals Inc.ANDACurrent
43063-170Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-544Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-544Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-544Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-554Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-554Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-554Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-774Paroxetineparoxetine hydrochloride hemihydrateMylan Institutional Inc.ANDACurrent
51079-774Paroxetineparoxetine hydrochloride hemihydrateMylan Institutional Inc.ANDACurrent
53808-0393ParoxetineParoxetine hydrochloride hemihydrateState of Florida DOH Central PharmacyANDACurrent
53808-0394ParoxetineParoxetine hydrochloride hemihydrateState of Florida DOH Central PharmacyANDACurrent
53808-0601ParoxetineParoxetine hydrochloride hemihydrateState of Florida DOH Central PharmacyANDACurrent
53808-0655ParoxetineParoxetine hydrochloride hemihydrateState of Florida DOH Central PharmacyANDACurrent
55154-5087ParoxetineParoxetine hydrochloride hemihydrateCardinal HealthANDACurrent
55154-5087ParoxetineParoxetine hydrochloride hemihydrateCardinal HealthANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-037Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-053Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-053Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-053Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-053Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-053Paroxetineparoxetine hydrochloride hemihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
58517-160paroxetine hydrochlorideparoxetine hydrochlorideNew Horizon Rx Group, LLCANDACurrent
70518-1658Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1658Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
71610-204Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-243Paroxetineparoxetine hydrochloride hemihydrateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
44397ORIG2008-03-21