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Medicines · US (FDA)

FDA 2016

FDA

Methylphenidate Hydrochloride

Approved 21 Oct 2016OralTablet, extended release

The FDA lists this product in 60 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: METHYLPHENIDATE HYDROCHLORIDE 27MG

Strengths and forms

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

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA205327-004 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseANDA205327-002 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 72MG · Tablet, extended releaseANDA205327-005 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA205327-003 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA205327-001 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SolutionANDA207485-002 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SolutionANDA207485-001 · Prescription
METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA207515-004 · Discontinued
METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended release

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.

ANDA207515-002 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA207515-003 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA207515-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 10MG · TabletANDA209753-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · TabletANDA209753-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 5MG · TabletANDA209753-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SolutionANDA211647-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SolutionANDA211647-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA214447-004 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseANDA214447-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA214447-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA214447-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · TabletANDA085799-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 20MG · TabletANDA086428-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 60MG · Capsule, extended releaseANDA203583-006 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 40MG · Capsule, extended releaseANDA203583-004 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · Capsule, extended releaseANDA203583-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 50MG · Capsule, extended releaseANDA203583-005 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 30MG · Capsule, extended releaseANDA203583-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · Capsule, extended releaseANDA203583-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SolutionANDA204602-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SolutionANDA204602-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · Tablet, extended releaseANDA207488-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · Tablet, extended releaseANDA207488-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA210818-004 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseANDA210818-002 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA210818-003 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA210818-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SolutionANDA201466-002 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SolutionANDA201466-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA206726-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA206726-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA206726-004 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseThis page

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA208607-003 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA208607-001 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA208607-004 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseANDA208607-002 · Discontinued

METHYLPHENIDATE HYDROCHLORIDE 60MG · Capsule, extended releaseANDA211796-005 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 30MG · Capsule, extended releaseANDA211796-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · Capsule, extended releaseANDA211796-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 40MG · Capsule, extended releaseANDA211796-004 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · Capsule, extended releaseANDA211796-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · Tablet, extended releaseANDA212288-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 36MG · Tablet, extended releaseANDA213473-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 18MG · Tablet, extended releaseANDA213473-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 54MG · Tablet, extended releaseANDA213473-004 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 27MG · Tablet, extended releaseANDA213473-002 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 72MG · Tablet, extended releaseANDA217229-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 30MG · Capsule, extended releaseANDA077707-003 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · Capsule, extended releaseANDA077707-001 · Prescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · Capsule, extended releaseANDA077707-002 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA206726.

Open Drugs@FDA

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: Methylphenidate Hydrochloride
Route: Oral
Dosage form: Tablet, extended release
Applicant: Aurolife Pharma LLC
Status: Prescription
FDA approval: 21 Oct 2016
Application: ANDA206726-002