Home Applications 021011 Application 021011
Type NDA
Sponsor SPECGX LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Yes Yes 002 ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Yes No 003 ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021011-001 ROXICODONE OXYCODONE HYDROCHLORIDE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 N021011-002 ROXICODONE OXYCODONE HYDROCHLORIDE 30MG TABLET / ORAL AB RLD 2000-08-31 N021011-003 ROXICODONE OXYCODONE HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 2009-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 2026-08-18 06:07:40 2026-07 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-002 ROXICODONE 30MG TABLET / ORAL AB RLD 2000-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021011-003 ROXICODONE 5MG TABLET / ORAL AB RLD 2009-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021011-001 ROXICODONE 15MG TABLET / ORAL AB RLD, RS 2000-08-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 23635-580 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-580 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-580 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-580 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-581 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current 23635-582 Roxicodone oxycodone hydrochloride SpecGx LLC NDA Current