Home Applications 202080 Application 202080
Type NDA
Sponsor ZYLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXAYDO OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG No No 002 OXAYDO OXYCODONE HYDROCHLORIDE TABLET;ORAL 7.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202080-001 OXAYDO OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL RLD 2011-06-17 N202080-002 OXAYDO OXYCODONE HYDROCHLORIDE 7.5MG TABLET / ORAL RLD 2011-06-17
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 3 · 88 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 2026-10-15 13:18:30 2026-09 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202080-001 OXAYDO 5MG TABLET / ORAL RLD 2011-06-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202080-002 OXAYDO 7.5MG TABLET / ORAL RLD 2011-06-17 4b0b4de00fa7…
Observed Orange Book patent history# Patent history page 4 of 9 · 340 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-001 9492443 2024-05-26 Drug product 2016-11-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-001 7201920 2025-03-16 Drug product 2011-07-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 7510726 2023-11-26 Drug product 2011-07-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 7981439 2023-11-26 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 8409616 2023-11-26 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 8637540 2023-11-26 Drug product 2014-02-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 9492443 2024-05-26 Drug product 2016-11-18 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202080-002 7201920 2025-03-16 Drug product 2011-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202080-001 7510726 2023-11-26 Drug product 2011-07-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-001 7981439 2023-11-26 Drug product 2011-09-09 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-001 8409616 2023-11-26 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-001 8637540 2023-11-26 Drug product 2014-02-20 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-001 9492443 2024-05-26 Drug product 2016-11-18 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-001 7201920 2025-03-16 Drug product 2011-07-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 7510726 2023-11-26 Drug product 2011-07-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 7981439 2023-11-26 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 8409616 2023-11-26 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 8637540 2023-11-26 Drug product 2014-02-20 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 9492443 2024-05-26 Drug product 2016-11-18 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202080-002 7201920 2025-03-16 Drug product 2011-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202080-001 7510726 2023-11-26 Drug product 2011-07-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-001 7981439 2023-11-26 Drug product 2011-09-09 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-001 8409616 2023-11-26 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-001 8637540 2023-11-26 Drug product 2014-02-20 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-001 9492443 2024-05-26 Drug product 2016-11-18 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-001 7201920 2025-03-16 Drug product 2011-07-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 7510726 2023-11-26 Drug product 2011-07-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 7981439 2023-11-26 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 8409616 2023-11-26 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 8637540 2023-11-26 Drug product 2014-02-20 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 9492443 2024-05-26 Drug product 2016-11-18 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202080-002 7201920 2025-03-16 Drug product 2011-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202080-001 7510726 2023-11-26 Drug product 2011-07-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-001 7981439 2023-11-26 Drug product 2011-09-09 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-001 8409616 2023-11-26 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-001 8637540 2023-11-26 Drug product 2014-02-20 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-001 9492443 2024-05-26 Drug product 2016-11-18 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-001 7201920 2025-03-16 Drug product 2011-07-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-002 7510726 2023-11-26 Drug product 2011-07-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202080-002 7981439 2023-11-26 Drug product c0c555d07b60…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US LLC cff0c64a-63f5-4b3c-909a-cdecf6755cbe 2026-01-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202080 application number: NDA202080 ndc (product): 69344-213 ndc (product): 69344-113
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Egalet US Inc. NDA Current 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-113 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Egalet US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current 69344-213 OXAYDO OXYCODONE HYDROCHLORIDE Zyla Life Sciences US Inc. NDA Current