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 2 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERhodes Pharmaceuticals LLCa5162476-1217-41c0-bc7e-0a0f123f069f2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
RoxicodoneOXYCODONE HYDROCHLORIDESpecGx LLC5a8157d3-ba20-4abf-b0d4-6ad141b31d632026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackff7f1268-ddb7-4742-beee-8b12966fe8f92026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEGenus Lifesciences Inc.6869fec9-1837-4221-afd8-5cc6fadd025d2026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack6de58d48-d6fc-46b4-ab7c-9ffdede855dc2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacka1e539ba-2cb5-4815-8c58-37abfd978fa52026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack7503ef9d-0fad-421f-951a-f35ab71f71c72026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack22f9eeaa-8aad-44f6-8258-e41edb60f8762026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke0079cc8-3642-47f0-9d14-28fd8f212c212026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1a190488-3444-43b0-b9c8-45c1eb371aad2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack35030c55-47e6-44cb-9d96-0c3cd5d0c2382026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.bdade691-3687-3308-e053-2995a90ad6ed2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEANI Pharmaceuticals, Inc.819ed9fc-0a21-4ed0-9080-91912c5f8ce22026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEMAJOR PHARMACEUTICALSe4fbf3fd-8755-4699-9a61-ba7fada0f93f2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEANI Pharmaceuticals, Inc.5df92fed-6194-4905-9ef2-9eed0d2e80862026-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEHikma Pharmceuticals USA Inc.d8e87c66-f872-4e1d-9ade-ef11490af63b2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: oxycodone hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Inc685f409f-946f-4b7e-8130-5ad7b92a5e7a2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDECamber Pharmaceuticals Inc01db4606-d49c-4b10-a78a-1cf41880a9fb2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEMAJOR PHARMACEUTICALS6d249bc5-79c4-4c42-a71b-d667c75163db2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
RoxyBondOXYCODONE HYDROCHLORIDEProtega Pharmaceuticals Inc72398542-8e0a-47b2-afeb-9ca5a1f150832026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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