FDA.reportPublic FDA data

Application 077822

Type
ANDA
Sponsor
MALLINCKRODT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL10MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL20MGNoNo
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL40MGNoNo
004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET, EXTENDED RELEASE; ORAL80MGNoNo

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 3 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEStrides Pharma Science Limitedf3116ebf-d72c-4e98-aa50-006be4770c862026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXAYDOOXYCODONE HYDROCHLORIDEZyla Life Sciences US LLCcff0c64a-63f5-4b3c-909a-cdecf6755cbe2026-01-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEAlvogen, Inc.20bb6bb4-230a-c9c2-01d8-a6e9341e96ba2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.056bdaac-4a43-42f0-9435-f349d3ccc1282025-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAurolife Pharma, LLC96ad4352-fff3-46a7-85de-466cc161045e2025-12-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERedpharm Drug3745020d-df8c-7209-e063-6394a90aabd72025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERedpharm Drug439c2de6-3ea5-e829-e063-6294a90aa77d2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma73b063b5-24b7-40bf-bc2a-c0e1bfaf61d12025-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health Packagingaa7ac2bf-d9ed-445d-b394-4d3fe39780ca2025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack08977126-9671-4d87-9724-1599ca86e1812025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3cd01fb7-b59c-fc5d-e063-6394a90a21d22025-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3ca9f0d9-a40d-4416-e063-6394a90aec8b2025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.92614a3a-331d-16ad-e053-2a95a90a47cc2025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAmerican Health Packaging0a6b0659-6816-4f44-81bd-9bac4da5380d2025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke2e52a0e-a80b-4225-b034-37a62f839d922025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.c10cc127-8756-4ddc-9f46-1e003ef271dc2025-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products LLC4cadb809-157d-49cc-97b4-3276594f19d22024-12-19Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEPrecision Dose, Inc.f849c7cc-fa85-47eb-be30-1be137913bf92024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackd9841f2d-d182-4888-9a3c-68e1afb3e19c2024-11-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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