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
- Generic approved · ANDA 220869, Rubicon Research · 011265-002Approved 23 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218264, Hetero Labs Ltd Iii · 011265-002Approved 12 Mar 2026Detected 25 Oct 2026Historical import
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· 002 · RLD | syrup, oral | 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |