FDA.reportPublic FDA data

Application 090773

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE; ORAL20MGNoNo
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE; ORAL30MGNoNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED RELEASE; ORAL60MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.caef6f50-1571-4ec7-8f8c-42b924d323ee2025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df61b895-c358-827b-e053-2995a90a9b602024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEAurobindo Pharma Limited3adfceb3-5f89-4bcf-b874-e3cb572a98b62024-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack41876761-9d5b-4190-a200-6a822c54582e2024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack0c82422a-d493-4dda-8626-0d9baa25db8c2024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca376622-d32c-4e6e-8af4-8e24a8d20d832024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEA-S Medication Solutionsbe33f3cb-6fd1-4377-816e-84bd49370e9e2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEA-S Medication Solutions3eb24fa9-921b-4bdb-9e0a-c82cb600df0f2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack675f999d-46b2-45da-b17e-58cc2ba180b12024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb1f1345c-3b7f-4228-b7b7-b9a4648050e52024-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBluePoint Laboratoriesa95cc04c-58e9-487f-8992-ef30df03a3cd2024-02-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP41c86c02-68c0-4db5-af1a-941b0d2ffe112024-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEMARKSANS PHARMA LIMITED3686cde5-f76d-4d16-aa5d-caceb8408f8c2023-10-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEProficient Rx LPf5e7503a-b28f-4cd0-a4ee-47bdca88d54b2023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdcfd62c7-1687-4e9b-9ae4-5a44929ac7652023-09-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP22a8cc15-17fb-4c4e-8d2a-de5755ed60312022-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEProficient Rx LP51c342c9-b9c6-467d-8fea-b73d72e3febc2021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEProficient Rx LPc34f6115-f447-450f-8c83-58f3c51a76c92021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb102b8e6-d58f-419c-bb35-720bafa132942020-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE DELAYED-RELEASEDULOXETINE HYDROCHLORIDEProficient Rx LP407b62b9-5b32-4bac-a2b0-7df4992792482019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE