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Medicines · US (FDA)
Kinase inhibitors

FDA 2019

Mammalian target of rapamycin (mTOR) kinase inhibitors

Sirolimus

Approved 22 Oct 2019OralSolution

The FDA lists this product in 18 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: SIROLIMUS 1MG/ML

Strengths and forms

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

SIROLIMUS 1MG/ML · SolutionThis page
SIROLIMUS 1MG/ML · SolutionANDA216728-001 · Prescription
SIROLIMUS 1MG/ML · SolutionANDA211212-001 · Prescription
SIROLIMUS 1MG · TabletANDA214753-002 · Prescription
SIROLIMUS 2MG · TabletANDA214753-003 · Prescription
SIROLIMUS 0.5MG · TabletANDA214753-001 · Prescription
SIROLIMUS 2MG · TabletANDA208691-003 · Prescription
SIROLIMUS 0.5MG · TabletANDA208691-001 · Prescription
SIROLIMUS 1MG · TabletANDA208691-002 · Prescription
SIROLIMUS 2MG · TabletANDA201676-002 · Prescription
SIROLIMUS 0.5MG · TabletANDA201676-003 · Prescription
SIROLIMUS 1MG · TabletANDA201676-001 · Prescription
SIROLIMUS 1MG/ML · Solution

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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.

ANDA215016-001 · Discontinued

SIROLIMUS 1MG/ML · SolutionANDA215080-001 · Prescription

SIROLIMUS 1MG/ML · SolutionANDA215116-001 · Prescription

SIROLIMUS 1MG · TabletANDA201578-001 · Prescription

SIROLIMUS 2MG · TabletANDA201578-002 · Prescription

SIROLIMUS 1MG/ML · SolutionANDA211040-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA211406.

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: Sirolimus
Drug class: Mammalian target of rapamycin (mTOR) kinase inhibitors, Other ophthalmologicals
Group: Kinase inhibitors
Route: Oral
Dosage form: Solution
Applicant: Apotex
Status: Prescription
FDA approval: 22 Oct 2019
Application: ANDA211406-001
RxCUI: 35302

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