FDA.reportPublic FDA data

Application 087742

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ASPIRIN (HALF-STRENGTH)ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATETABLET;ORAL325MG;2.25MG;0.19MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-043f01610625f2…
2019-09-15 20:21 UTC2019-09A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087742-001OXYCODONE AND ASPIRIN (HALF-STRENGTH)325MG;2.25MG;0.19MGTABLET / ORAL1982-06-04e64feba35796…