FDA.reportPublic FDA data

Application 077584

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
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#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-5576ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5577ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5578ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5579ParoxetineParoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-101ParoxetineParoxetine HydrochlorideRebel Distributors CorpANDACurrent
21695-103ParoxetineParoxetine HydrochlorideRebel Distributors CorpANDACurrent
21695-104ParoxetineParoxetine HydrochlorideRebel Distributors CorpANDACurrent
33261-090ParoxetineParoxetineAidarex Pharmaceuticals LLCANDACurrent
33261-091ParoxetineParoxetineAidarex Pharmaceuticals LLCANDACurrent
49999-632PAROXETINEParoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-632PAROXETINEParoxetine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-828ParoxetineParoxetine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50436-3933ParoxetineParoxetineUnit Dose ServicesANDACurrent
51655-356ParoxetineParoxetineNorthwind PharmaceuticalsANDACurrent
51655-356ParoxetineParoxetineNorthwind PharmaceuticalsANDACurrent
52959-775ParoxetineParoxetine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-776ParoxetineParoxetine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53002-1174ParoxetineParoxetineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1174ParoxetineParoxetineRPK Pharmaceuticals, Inc.ANDACurrent
53808-0682ParoxetineParoxetine Hydrochloride HemihydrateState of Florida DOH Central PharmacyANDACurrent
54458-988ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
54458-988ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
54458-989ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
54458-989ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
54458-990ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
54458-990ParoxetineParoxetine hydrochlorideInternational Laboratories, LLCANDACurrent
55154-4753ParoxetineParoxetine HydrochlorideCardinal HealthANDACurrent
55154-4753ParoxetineParoxetine HydrochlorideCardinal HealthANDACurrent
55154-6640ParoxetineParoxetine HydrochlorideCardinal HealthANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-972ParoxetineParoxetinePD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-0183ParoxetineParoxetineClinical Solutions Wholesale, LLCANDACurrent
58118-0183ParoxetineParoxetineClinical Solutions Wholesale, LLCANDACurrent
58118-0183ParoxetineParoxetineClinical Solutions Wholesale, LLCANDACurrent
60760-398ParoxetineParoxetineSt. Mary's Medical Park PharmacyANDACurrent
60760-501ParoxetineParoxetineSt. Mary's Medical Park PharmacyANDACurrent
61919-513PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-596PAROXETINEPAROXETINEDirectRXANDACurrent
61919-658PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-658PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-658PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-658PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-658PAROXETINEPAROXETINEDIRECT RXANDACurrent
63187-105ParoxetineParoxetineProficient Rx LPANDACurrent
63187-105ParoxetineParoxetineProficient Rx LPANDACurrent
63187-190ParoxetineParoxetineProficient Rx LPANDACurrent
63187-190ParoxetineParoxetineProficient Rx LPANDACurrent
63187-434ParoxetineParoxetineProficient Rx LPANDACurrent
63187-434ParoxetineParoxetineProficient Rx LPANDACurrent
63629-1840ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63629-1840ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63629-3349ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63629-3349ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63629-3349ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63629-8114ParoxetineParoxetineBryant Ranch PrepackANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-888ParoxetineParoxetineMcKesson CorporationANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-888ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson CorporationANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
63739-963ParoxetineParoxetineMcKesson Corporation dba SKY PackagingANDACurrent
64725-0098ParoxetineParoxetineTYA PharmaceuticalsANDACurrent
64725-0197ParoxetineParoxetineTYA PharmaceuticalsANDACurrent
65084-888ParoxetineParoxetineMcKesson Corporation dba RX PakANDACurrent
65084-888ParoxetineParoxetineMcKesson Corporation dba RX PakANDACurrent