BACLOFEN | N021589 | UCB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4665 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Baclofen Orally Disintegrating Tablets, 5 mg suitable for submission as an ANDA, representing a change in strength from the reference li | Suitability | 2026-04-28 | Open | Lachman Consulting Services |
Citizen Petition from Pharmobedient Consulting, LLC FDA-2023-P-4587 Pharmobedient Consulting, LLC filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug KEMSTRO (baclofen) orally disintegrating tablet, 10 mg and 20 mg, NDA 021589, was withdrawn from commercial dist | 505(q) | 2023-10-18 | Withdrawn | Pharmobedient Consulting |
Attachment 1 - FDA Electronic Orange Book printout for Baclofen products Labe... FDA-2019-P-3423 Oxford Pharmaceuticals LLC filed this petition regarding baclofen tablets, specifically requesting clarification on the suitability of the Ivax/Teva baclofen tablet formulation for bioequivalence purposes under the abbreviated new drug application pathway. | Suitability | 2019-07-17 | Open | Oxford Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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