diphenhydramine hydrochloride · Mcneil Cons · NDA 009486
Benadryl Preservative Free
Earliest generic entry, as listed
Open now
No marketed reference-listed strength; date taken from all listed strengths.
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 205337, Avet Lifesciences · 009486-001Approved 14 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 009486 · 001 · RLD · discontinued | injectable, injection | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |