MEXILETINE HYDROCHLORIDE | N018873 | BOEHRINGER INGELHEIM
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-0431 Senores Pharmaceuticals, Inc. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Mexiletine Hydrochloride Capsules in 100 mg, 300 mg, and 400 mg strengths suitable for submission as an ANDA, with the reference listed dr | Suitability | 2026-01-16 | Open | Senores Pharmaceuticals |
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2023-P-2157 Rising Pharma Holdings, Inc. submitted a suitability petition on May 26, 2023, requesting approval to file an Abbreviated New Drug Application for Mexiletine Hydrochloride Capsules USP at a new 300 mg strength, which differs from the reference listed drug MEXITIL capsules at 150 mg, 200 mg, and 250 | Suitability | 2023-05-26 | Open | Rising Pharma Holdings |
Citizen Petition from Hetero Labs Limited FDA-2019-P-2982 Hetero Labs Limited filed a citizen petition requesting that the FDA Commissioner determine whether Boehringer Ingelheim Pharmaceuticals' Mexitil (Mexiletine Hydrochloride) capsules 150 mg, 200 mg, and 250 mg, NDA #018873, was voluntarily withdrawn from sale for reasons other than safety or effectiv | 505(q) | 2019-06-20 | Denied | Hetero Labs Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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