Application 091313

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL15MGNoNo
003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL30MGNoNo
004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL10MGNoNo
005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDETABLET;ORAL20MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091313-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-18
A091313-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-18
A091313-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-18
A091313-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-29
A091313-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-29

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-2984e616aacf4f…
2026-09-14 22:38:342026-08A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091313-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2011-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091313-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2011-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091313-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2011-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091313-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2016-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091313-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2016-04-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091313-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091313-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091313-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091313-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091313-005AB174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A091313-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091313-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091313-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091313-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091313-005AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091313-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091313-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091313-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091313-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091313-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091313-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091313-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091313-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091313-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091313-005AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091313-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091313-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091313-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091313-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091313-005AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091313-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091313-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091313-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091313-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091313-005AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091313-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091313-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091313-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091313-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091313-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091313-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091313-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091313-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091313-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091313-005AB1b00525d2431f…

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
52959-130Oxycodone HydrochlorideOxycodone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68308-108Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-108Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-108Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-110Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-110Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-110Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-111Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-111Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-111Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-112Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-112Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-112Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-120Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-120Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-120Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-505Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-505Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent
68308-505Oxycodone HydrochlorideOxycodone HydrochlorideMayne Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76110ORIG 2023-11-02