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 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy585405bc-8b85-286f-e063-6394a90aa5cd2026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-Tech, Inc.744f5d1c-7427-492c-8994-c8e817793e532026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy57afed61-79db-ca43-e063-6394a90a68eb2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONEMajor Pharmaceuticals6b6db42b-9821-4aa6-8566-297037d840792026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Incc801963d-f54d-4ed5-82c4-8b278528d3dc2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackbb33bf7f-aa70-4e8a-91b2-4e0400dc328e2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OxyContinOXYCODONE HYDROCHLORIDEKnoa Pharma LLCbfdfe235-d717-4855-a3c8-a13d26dadede2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONEAmneal Pharmaceuticals LLC094b64b3-cd32-4de5-afb6-ea00d9caad742026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack0e4dd113-87ab-4a5d-846a-446db3cfd4692026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke84ea009-3cab-4721-bd21-1123eccce5152026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCe73897d6-b920-4300-a564-5dbc9c8e9fe92026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedpharm Drug5301d432-7fca-2d72-e063-6394a90a18a42026-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack27124cdf-a3e8-474c-9c1e-6fa48f6ddc052026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONERedpharm Drug525001a6-68d8-7ef7-e063-6294a90abc5f2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY424fdfc7-1c92-2e62-e063-6394a90a136b2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
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