FDA.reportPublic FDA data

Application 203088

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASENoNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASENoNo
004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-025DULOXETINEDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-106DULOXETINEDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-960DULOXETINEDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-815DuloxetineDULOXETINE HYDROCHLORIDEmedsource pharmaceuticalsANDACurrent
50090-2226DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2226DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2226DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3028DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3205DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3205DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3205DuloxetineDULOXETINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50436-0747DuloxetineDULOXETINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0748DuloxetineDULOXETINE HYDROCHLORIDEUnit Dose ServicesANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-746DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-747DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-748DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-750DuloxetineDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
53217-130DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEAidarex Pharmaceuticals LLCANDACurrent
55700-505DULOXETINEDULOXETINE HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-164DULOXETINEDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-164DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DULOXETINEDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-165DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DULOXETINEDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-166DuloxetineDULOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEDirect_RxANDACurrent
61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEDirect_RxANDACurrent
61919-422DULOXETINEDULOXETINEDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54331ORIG2018-05-24