FDA.reportPublic FDA data

Application 203854

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002PAROXETINEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo
003PAROXETINEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
004PAROXETINEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7985Paroxetineparoxetine hydrochloride hemihydrateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7985Paroxetineparoxetine hydrochloride hemihydrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7985Paroxetineparoxetine hydrochloride hemihydrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8173ParoxetineParoxetineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8173ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8173ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8174ParoxetineParoxetineNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8174ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8174ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43547-347Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-347Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-347Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-347Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-348Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-348Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-348Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-348Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-349Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-349Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-349Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-349Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-350Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-350Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-350Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
43547-350Paroxetineparoxetine hydrochloride hemihydrateSolco Healthcare US, LLCANDACurrent
50090-4207Paroxetineparoxetine hydrochloride hemihydrateA-S Medication SolutionsANDACurrent
50090-4207Paroxetineparoxetine hydrochloride hemihydrateA-S Medication SolutionsANDACurrent
50090-4838Paroxetineparoxetine hydrochloride hemihydrateA-S Medication SolutionsANDACurrent
50090-5987Paroxetineparoxetine hydrochloride hemihydrateA-S Medication SolutionsANDACurrent
52817-140Paroxetineparoxetine hydrochlorideTrupharma, LLCANDACurrent
52817-141Paroxetineparoxetine hydrochlorideTrupharma, LLCANDACurrent
52817-142Paroxetineparoxetine hydrochlorideTrupharma, LLCANDACurrent
52817-143Paroxetineparoxetine hydrochlorideTrupharma, LLCANDACurrent
53002-2174Paroxetineparoxetine hydrochloride hemihydrateRPK Pharmaceuticals, Inc.ANDACurrent
55700-379Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA QuaANDACurrent
55700-379Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-379Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-379Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-503Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA QuaANDACurrent
55700-503Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-503Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-503Paroxetineparoxetine hydrochloride hemihydrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-927Paroxetineparoxetine hydrochloride hemihydrateProficient Rx LPANDACurrent
63187-927Paroxetineparoxetine hydrochloride hemihydrateProficient Rx LPANDACurrent
63187-927Paroxetineparoxetine hydrochloride hemihydrateProficient Rx LPANDACurrent
63187-927Paroxetineparoxetine hydrochloride hemihydrateProficient Rx LPANDACurrent
68071-3278Paroxetineparoxetine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6977Paroxetineparoxetine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6985Paroxetineparoxetine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7677Paroxetineparoxetine hydrochloride hemihydratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7677Paroxetineparoxetine hydrochloride hemihydratePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0320Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0320Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-0550Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1210Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1210Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1253Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1253Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1253Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1253Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1284Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1284Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1406Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1406Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1406Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-1406Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2182Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2182Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2182Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2182Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2182Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2376Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2376Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2376Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent
70518-2376Paroxetineparoxetine hydrochloride hemihydrateREMEDYREPACK INC.ANDACurrent