FDA.report

Application 075356

Type
ANDA
Sponsor
APOTEX

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
0904-5676PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5676PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5676PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5676PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5676PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5677PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5677PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5677PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5677PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5677PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5678PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5678PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5678PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5678PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5679PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5679PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5679PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-5679PAROXETINEparoxetine hydrochlorideMajor PharmaceuticalsANDACurrent
10544-433PAROXETINEparoxetine hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-809PAROXETINEparoxetine hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
12634-248PAROXETINEparoxetine hydrochlorideApotheca Inc.ANDACurrent
50090-0849PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0849PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0849PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-0922PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1296PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1296PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-1296PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
50090-5566PAROXETINEparoxetine hydrochlorideA-S Medication SolutionsANDACurrent
53217-177PAROXETINEparoxetine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53808-0748paroxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0750paroxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0753paroxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0754paroxetinePAROXETINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-1000PAROXETINEparoxetine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-7999PAROXETINEparoxetine hydrochlorideCardinal HealthANDACurrent
55154-7999PAROXETINEparoxetine hydrochlorideCardinal Health 107, LLCANDACurrent
60429-734PAROXETINEparoxetine hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-734PAROXETINEparoxetine hydrochlorideGolden State Medical SupplyANDACurrent
60429-734PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-734PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-735PAROXETINEparoxetine hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-735PAROXETINEparoxetine hydrochlorideGolden State Medical SupplyANDACurrent
60429-735PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-735PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-736PAROXETINEparoxetine hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-736PAROXETINEparoxetine hydrochlorideGolden State Medical SupplyANDACurrent
60429-736PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-736PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-737PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-737PAROXETINEparoxetine hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-737PAROXETINEparoxetine hydrochlorideGolden State Medical SupplyANDACurrent
60429-737PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-737PAROXETINEparoxetine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0083PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0084PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0097PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
237610ORIG12005-08-01FDA source fallback
308600ORIG12003-07-31FDA source fallback