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Tab 26 - Belbuca Clinical Pharmacology and Biopharmaceutics Review Excerpt

FDA-2026-P-4762-0028Supporting & Related Material
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Title
Tab 26 - Belbuca Clinical Pharmacology and Biopharmaceutics Review Excerpt
Posted
May 1, 2026
Agency
Food and Drug Administration (FDA)
Topics
  • Mental Health & Substance Abuse
  • Pharmaceutical Policy
View on regulations.gov ↗
Related

Related documents

Other documents filed with this rulemaking.

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Supporting & Related Material
Tab 18 - Belbuca REMS
No comment periodMay 1, 2026
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Tab 21 - Onsolis Clinical Pharmacology Review Excerpt
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Tab 27 - FDA Guidance on IR SUPAC
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Tab 20 - Suboxone Clinical Pharmacology Review Excerpt
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Tab 19 - FDA Draft Guidance on Buprenorphine Hydrochloride Buccal 2025
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Tab 14 - Belbuca PI
No comment periodMay 1, 2026
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Tab 31 - Olechno et al 2026 Excerpt
No comment periodMay 1, 2026
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Tab 16 - Belbuca Summary Review Excerpt
No comment periodMay 1, 2026

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