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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals, Inc.3eddd18b-695a-4e53-a76c-f6779515b9182024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ef58f422-682e-6896-e053-2a95a90a1f2d2024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1bcddbe1-c453-43ec-a822-9e993b885a5f2024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack261132f9-ab96-4901-a660-a80c3e0f9d862024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.1bb147d4-1ab6-dd70-e063-6394a90a67a82024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackb2510d72-bf63-4c9d-ac5e-7bacd993fa102024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack232d44d2-3924-4d35-873c-d2aef75e9a412024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackd248ceba-9492-4348-aa07-31c9c73a36202024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackbc7fdf7e-ad4e-4a04-b35c-2233cc7e5f152024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack4e9e945d-5ffc-48de-99fa-3fb36c5bc2b92024-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack9da42120-0214-45cb-bb98-9a7739e72d432024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.17f7946d-e889-b736-e063-6394a90a42e02024-05-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals,Inc.801cb437-c189-44f5-83eb-a51c365d8a6b2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENovel Laboratories, Inc.69410bf3-0d3a-41f9-b10a-c4ee3770f7282023-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC391701e5-2035-43fa-91ce-d27a1af194922023-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXYCODONE HYDROCHLORIDE
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEpic Pharma, LLCcff1eee3-7c02-4f6c-acc5-1f6dcbab92c02022-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEXLCare Pharmaceuticals, Ince5c8e72d-4ac5-4ca3-9557-6a659d4d83382021-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxycodone Hydrochloride
generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAscent Pharmaceuticals Incde96e2be-66d9-4bcb-a133-221ad32e09f12017-07-10Boxed 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.