Dextromethorphan / Quinidine Oral Capsule
- Brand(s)
- Nuedexta
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Avanir Pharmaceuticals, Inc. (2015-01-30)
- Oldest Current Product
- 2010-12-01
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\DEXTROMETHORPHAN:QUINIDINE
- FDAOB
- ORAL\CAPSULE\DEXTROMETHORPHAN HYDROBROMIDE: QUINIDINE SULFATE
- SPL Active
- ORAL\CAPSULE, GELATIN COATED\DEXTROMETHORPHAN HYDROBROMIDE: QUINIDINE SULFATE
- SPL Moiety
- ORAL\CAPSULE, GELATIN COATED\DEXTROMETHORPHAN: QUINIDINE
product(s) by strength(s)
dextromethorphan hydrobromide 20 mg / quinidine sulfate 10 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 645970301 | Nuedexta | NDA | Avanir Pharmaceuticals, Inc. | 2010-12-01 | DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE | ORAL | CAPSULE, GELATIN COATED | NDA021879 | 484e0918-3442-49dc-8ccf-177f1f3ee9f3 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021879 | NUEDEXTA | AVANIR PHARMACEUTICALS INC | 2010-10-29 | pRE38115, SUBSTANCE p8227484, TREATMENT OF PSEUDOBULBAR AFFECT p7659282, TREATMENT OF PSEUDOBULBAR AFFECT | NDA021879_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA021879_001 | RX | DEXTROMETHORPHAN HYDROBROMIDE (20MG), QUINIDINE SULFATE (10MG) | ORAL | CAPSULE | True | 2010-10-29 | NUEDEXTA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7659282 (view patent) | 2026-08-13 | NDA021879 |
| 2 | p8227484 (view patent) | 2023-07-17 | NDA021879 |
| 3 | pRE38115 (view patent) | 2016-01-26 | NDA021879 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 484e0918-3442-49dc-8ccf-177f1f3ee9f3 (view SPL) | These highlights do not include all the information needed to use NUEDEXTA safely and effectively.See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 | prescription | Human Prescription | Avanir Pharmaceuticals, Inc. | MANUFACTURE | 2015-01-30 | 12 | 645970301 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII