FDA.reportPublic FDA data

Application 076636

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076636-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06
A076636-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06
A076636-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-0784e616aacf4f…
2026-08-18 06:07:402026-07A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076636-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2004-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076636-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2015-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076636-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2004-02-06301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A076636-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076636-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076636-003AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A076636-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076636-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A076636-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076636-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076636-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A076636-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076636-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076636-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A076636-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076636-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076636-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A076636-003AB1ea99ee380514…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2876Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2876Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2876Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2878Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2878Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2878Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2878Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2879Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2879Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2879Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
0228-2879Oxycodone HydrochlorideOxycodone HydrochlorideActavis Pharma, Inc.ANDACurrent
10544-005Oxycodone HydrochlorideOxycodone HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
63629-4153oxycodone hydrochlorideoxycodone hydrochlorideBryant Ranch PrepackANDACurrent
68084-184Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-184Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-184Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-185Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-185Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-185Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76307ORIG 2023-11-03
8938ORIG2004-02-12