dextromethorphan hydrobromide; promethazine hydrochloride · Ani Pharms · NDA 011265
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
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
- 25 Oct 2026Generic approved · 011265-00223 Jun 2026
- 25 Oct 2026Generic approved · 011265-00212 Mar 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 011265 · 002 · RLD | syrup, oral | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |