Application 077290

Type
ANDA
Sponsor
NESHER PHARMS

Application Products#

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

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
A077290-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08
A077290-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08
A077290-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08
A077290-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08
A077290-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08

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 22:38:342026-08A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-0803ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077290-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-005AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077290-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077290-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077290-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-005AB1ea99ee380514…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6444Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6445Oxycodone HydrochlorideOxycodone HydrochlorideMajor PharmaceuticalsANDACurrent
50436-0156Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-0158OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-3182OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEUnit Dose ServicesANDACurrent
63629-3775OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-4606OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-4606OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-4606OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7399OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7399OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7399OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63739-177OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEMcKesson CorporationANDACurrent
63739-365OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEMcKesson CorporationANDACurrent
68084-048Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68084-828Oxycodone HydrochlorideOxycodone HydrochlorideAmerican Health PackagingANDACurrent
68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-793OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-794OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-795OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-796OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-797OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.ANDACurrent
71335-0115OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0115OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0115OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0174OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0209OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0209OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent