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Medicines · US (FDA)
Opioids

FDA 2021

Oripavine derivatives

Buprenorphine

Approved 3 May 2021TransdermalFilm, extended release

The FDA lists this product in 25 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BUPRENORPHINE 5MCG/HR

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BUPRENORPHINE 15MCG/HR · Film, extended releaseANDA210162-004 · Discontinued
BUPRENORPHINE 7.5MCG/HR · Film, extended releaseANDA210162-002 · Discontinued
BUPRENORPHINE 20MCG/HR · Film, extended releaseANDA210162-005 · Discontinued
BUPRENORPHINE 10MCG/HR · Film, extended releaseANDA210162-003 · Discontinued
BUPRENORPHINE 5MCG/HR · Film, extended releaseThis page
BUPRENORPHINE 15MCG/HR · Film, extended releaseANDA210272-004 · Prescription
BUPRENORPHINE 7.5MCG/HR · Film, extended releaseANDA210272-002 · Prescription
BUPRENORPHINE 20MCG/HR · Film, extended releaseANDA210272-005 · Prescription
BUPRENORPHINE 10MCG/HR · Film, extended releaseANDA210272-003 · Prescription
BUPRENORPHINE 5MCG/HR · Film, extended releaseANDA210272-001 · Prescription
BUPRENORPHINE 20MCG/HR · Film, extended release

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Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA211586-005 · Prescription

BUPRENORPHINE 10MCG/HR · Film, extended releaseANDA211586-003 · Prescription

BUPRENORPHINE 5MCG/HR · Film, extended releaseANDA211586-001 · Prescription

BUPRENORPHINE 15MCG/HR · Film, extended releaseANDA211586-004 · Prescription

BUPRENORPHINE 7.5MCG/HR · Film, extended releaseANDA211586-002 · Prescription

BUPRENORPHINE 10MCG/HR · Film, extended releaseANDA204937-002 · Prescription

BUPRENORPHINE 7.5MCG/HR · Film, extended releaseANDA204937-005 · Prescription

BUPRENORPHINE 15MCG/HR · Film, extended releaseANDA204937-003 · Prescription

BUPRENORPHINE 5MCG/HR · Film, extended releaseANDA204937-001 · Prescription

BUPRENORPHINE 20MCG/HR · Film, extended releaseANDA204937-004 · Prescription

BUPRENORPHINE 5MCG/HR · Film, extended releaseANDA207490-001 · Prescription

BUPRENORPHINE 20MCG/HR · Film, extended releaseANDA207490-004 · Prescription

BUPRENORPHINE 10MCG/HR · Film, extended releaseANDA207490-002 · Prescription

BUPRENORPHINE 7.5MCG/HR · Film, extended releaseANDA207490-005 · Discontinued

BUPRENORPHINE 15MCG/HR · Film, extended releaseANDA207490-003 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA210162.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Buprenorphine
Drug class: Oripavine derivatives, Drugs used in opioid dependence
Group: Opioids
Route: Transdermal
Dosage form: Film, extended release
Applicant: Mylan Tech Viatris
Status: Discontinued
FDA approval: 3 May 2021
Application: ANDA210162-001
RxCUI: 1819

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FDA 2019AlvimopanCapsule

FDA 2018Buprenorphine Hydrochloride and Naloxone Hydrochloridebuprenorphine hydrochloride · Film

FDA 2018Lucemyralofexidine hydrochloride · Tablet

FDA 2018Remifentanil HydrochlorideInjectable

FDA 2017Ibuprofen and Pseudoephedrine Hydrochlorideibuprofen · Capsule

FDA 2017Sublocadebuprenorphine · Solution, extended release

FDA 2017Buprenorphine Hydrochloride; Naloxone Hydrochloridebuprenorphine hydrochloride · Film

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FDA 2016Probuphinebuprenorphine hydrochloride · Implant

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