Home Applications 087794 Application 087794
Type ANDA
Sponsor SUN PHARM INDUSTRIES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;4.5MG;0.38MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087794-001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087794-001 OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG TABLET / ORAL 1982-05-26 f41ea6bd6efb…
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 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 76073 ORIG 2023-11-02