SUBUTEX

FDA-2025-P-5272

Athyna Pharma LLC submitted an amendment to its October 16, 2025 ANDA suitability petition for Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in new strengths of 16/4 mg, 12/3 mg, and 4/1 mg base, correcting the reference listed drug to NDA 020733 (Suboxone) and the refere

FDA-2025-P-5272

Athyna Pharma LLC filed this suitability petition requesting that the FDA declare Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in three new strengths (1.4 mg, 2.9 mg, and 5.7 mg) suitable for submission in an Abbreviated New Drug Application, referencing Indivior's appro

FDA-2025-P-4987

Athyna Pharma LLC submitted a citizen petition under FDC Act section 505(j)(2)(C) requesting FDA approval to file an abbreviated new drug application (ANDA) for Buprenorphine Hydrochloride Sublingual Tablets in new strengths of 4 mg, 12 mg, and 16 mg (equivalent to base), which differ from the Refer

FDA-2024-P-2909

The law firm Hyman, Phelps & McNamara, P.C., filed this Suitability Petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request that the FDA declare Buprenorphine Sublingual Tablets in 4 mg and 12 mg strengths suitable for submission as an A

FDA-2012-P-1034

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hydrochloride and naloxone hydrochloride) 2 mg/0.5 mg and 8 mg/2 mg, approved under NDA 20-733, were voluntarily withdrawn from s

FDA-2009-P-0459

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

FDA-2009-P-0325

Reckitt Benckiser Pharmaceuticals Inc. filed this citizen petition pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA require generic applicants submitting ANDAs and 505(b)(2) NDAs for Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone) s

FDA-2009-P-0289

Reckitt Benckiser Pharmaceuticals Inc. filed this citizen petition pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA require generic applicants submitting abbreviated new drug applications (ANDAs) and 505(b)(2) new drug applications for Subutex (b