---
brand_name: "BUPRENORPHINE"
generic_name: "BUPRENORPHINE"
slug: "buprenorphine-ansdermal-20mcg-hr"
canonical_url: "https://medichelpline.com/drug-index/buprenorphine-ansdermal-20mcg-hr"
content_type: "drug_monograph"
route: "TRANSDERMAL"
drug_class: "General Medications"
fda_updated_at: "2024-10-31T00:00:00.000Z"
license: "Drugs@FDA Public Domain / Informational Use"
---
# BUPRENORPHINE (BUPRENORPHINE)
## Clinical Monograph Metadata
- **Canonical URL:** https://medichelpline.com/drug-index/buprenorphine-ansdermal-20mcg-hr
- **Generic / Active Ingredient:** BUPRENORPHINE
- **Brand Name:** BUPRENORPHINE
- **Administration Route:** TRANSDERMAL
- **Pharmacological Class:** General Medications
- **FDA Data Timestamp:** 2024-10-31T00:00:00.000Z
## Primary Indication & Clinical Use
Marketing status: Prescription
## Monograph Summary

Approval overview BUPRENORPHINE is listed in Drugs@FDA under application 211586 (ANDA). Marketing status: Prescription Active ingredient BUPRENORPHINE Form and strength FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR Sponsor AMNEAL Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: SUPPL.

## Primary Sources & FDA Regulatory Records
- [Drugs@FDA Primary Database](https://www.accessdata.fda.gov/scripts/cder/daf/) (Reference Slug: `buprenorphine-ansdermal-20mcg-hr`)
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## Medical & Regulatory Disclaimer

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> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.