dextromethorphan hydrobromide; quinidine sulfate · Otsuka America Pharm · NDA 021879
Nuedexta
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 204196, Sun Pharm · 021879-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021879 · 001 · RLD | capsule, oral | 20MG;10MG | open |
Expired or delisted (1)
- US 7659282 · use U-1093 · 13 Aug 2026