Home Applications 021879 Application 021879
Type NDA
Sponsor AVANIR PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUEDEXTA DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE CAPSULE;ORAL 20MG;10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021879-001 NUEDEXTA DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021879-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021879-001 7659282 2026-08-13 U-1093
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 65 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59148-053 Nuedexta dextromethorphan hydrobromide and quinidine sulfate Otsuka America Pharmaceutical, Inc NDA Current 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA Current 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA Current 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA Current 64597-301 NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate Avanir Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 68755 SUPPL 2021-09-24 59035 SUPPL 2019-06-12 59026 SUPPL 2019-06-12 57521 SUPPL 2019-02-13 57396 SUPPL 2019-02-01 16508 SUPPL 2015-01-22 6362 SUPPL 2015-01-21 24223 ORIG 2011-06-09 21854 ORIG 2011-06-09 28760 ORIG 2010-11-03 16507 ORIG 2010-10-29