mexiletine hydrochloride · Boehringer Ingelheim · NDA 018873
Mexitil
Earliest generic entry, as listed · earliest of 3 marketed strengths
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 219987, Macleods Pharms · 018873-002Approved 23 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214598, Zydus Pharms · 018873-002Approved 23 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018873 · 002 · RLD · discontinued | capsule, oral | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018873 · 003 · RLD · discontinued | capsule, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018873 · 004 · RLD · discontinued | capsule, oral | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |