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Medicines · US (FDA)

FDA 2018

FDA

Roflumilast

Approved 6 Aug 2018OralTablet

The FDA lists this product in 20 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: ROFLUMILAST 250MCG

Strengths and forms

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

ROFLUMILAST 250MCG · TabletANDA212490-001 · Prescription
ROFLUMILAST 500MCG · TabletANDA212490-002 · Prescription
ROFLUMILAST 250MCG · TabletANDA208303-002 · Prescription
ROFLUMILAST 500MCG · TabletANDA208303-001 · Prescription
ROFLUMILAST 500MCG · TabletANDA213298-001 · Prescription
ROFLUMILAST 250MCG · TabletANDA213298-002 · Prescription
ROFLUMILAST 250MCG · TabletANDA208213-002 · Prescription
ROFLUMILAST 500MCG · TabletANDA208213-001 · Prescription
ROFLUMILAST 250MCG · TabletANDA208236-002 · Prescription
ROFLUMILAST 500MCG · TabletANDA208236-001 · Prescription
ROFLUMILAST 250MCG · TabletANDA208247-002 · Prescription
ROFLUMILAST 500MCG · TabletANDA208247-001 · Prescription
ROFLUMILAST 500MCG · TabletANDA208180-001 · Prescription
ROFLUMILAST 250MCG · Tablet

At a glance

Brand name: Roflumilast
Route: Oral
Dosage form: Tablet
Applicant: Torrent
Status: Discontinued
FDA approval: 6 Aug 2018
Application: ANDA208272-002

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.

ANDA208180-002 · Prescription

ROFLUMILAST 500MCG · TabletANDA208257-001 · Discontinued

ROFLUMILAST 500MCG · TabletANDA208272-001 · Discontinued

ROFLUMILAST 250MCG · TabletThis page

ROFLUMILAST 500MCG · TabletANDA208299-001 · Prescription

ROFLUMILAST 250MCG · TabletANDA208256-001 · Prescription

ROFLUMILAST 500MCG · TabletANDA208256-002 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA208272.

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.