FDA.reportPublic FDA data

Application 022516

Type
NDA
Sponsor
LILLY

Application Products#

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

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 1 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.00628e5e-4c5b-2573-e063-6294a90a0e3b2026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEYaopharma Co., Ltd.90224073-178d-7ec5-e053-2995a90a20fc2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEREMEDYREPACK INC.b9f20917-9529-4c62-bafe-baae7f8d6c772026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.29eacc40-cbec-4cc9-8556-773346617e852026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEQuallent Pharmaceuticals Health, LLC31362045-201f-45f3-99f2-a5e322a0c30b2025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine HydrochlorideDULOXETINE HYDROCHLORIDEMacleods Pharmaceuticals Limited177ce798-3924-416b-ba37-23dfa911a43b2025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
CymbaltaDULOXETINE HYDROCHLORIDEEli Lilly and Company2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba2025-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cymbalta
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3bae1317-4cc8-4d86-b1b6-15edee733a6d2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.2c233b3f-83de-40c4-9f1d-81f901f894592025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackf66f63c8-51db-4183-a452-78205cf3a2632025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack276ca221-354c-484d-93d5-0698cb2cfd562025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka23e79b3-7bd3-4b83-beb0-dc23d4830e9e2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka5804a0b-ceae-4ebd-bba0-bfc10e21b90d2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka891f20f-83ff-4960-81ef-9e74d01a452e2025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackc934cc41-b40b-4c5c-b019-a749eec52d882025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca36f94c-2215-436f-ada8-7319f4f3e0542025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackb25c01e0-273a-4f8f-a37e-9b17e5cf378f2025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22044ORIG2011-09-16
44768ORIG2010-12-01
29814ORIG2010-11-09
17668ORIG2010-11-05