BUPRENORPHINE HYDROCHLORIDE | N018401 | INDIVIOR INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Odin Pharmaceuticals LLC FDA-2023-P-4223 · 4 docket documents Odin Pharmaceuticals LLC filed this petition on September 27, 2023, pursuant to sections 505(j) and 505(w) of the FDC Act and implementing regulations, requesting that the FDA determine whether BUPRENEX (Buprenorphine Hydrochloride) Injection, 0.3 mg/mL, approved under NDA 018401 and held by Indivio | 505(q) | 2023-09-28 | Granted | Odin Pharmaceuticals LLC |
Lachman Consultant Sevices, Inc.- Citizen Petition FDA-2012-P-1034 · 5 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition requesting that the FDA determine whether SUBOXONE Sublingual Tablets (buprenorphine hydrochloride and naloxone hydrochloride) 2 mg/0.5 mg and 8 mg/2 mg, approved under NDA 20-733, were voluntarily withdrawn from s | 505(q) | 2012-10-01 | Denied | — |
Aerscher LLC - Citizen Petition FDA-2009-P-0459 · 4 docket documents Aerscher LLC filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to submit an ANDA for buprenorphine hydrochloride 8mg combined with naloxone hydrochloride 2mg in an orally soluble strip format marketed as Buprox, which differs fr | Other | 2009-10-22 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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