Skip to content

Sign in Start free

Create your free account

Loading your page…

We care for the people who care.

No ads. No selling of your data. No third-party trackers.

Apps

Prognia
Ward
Suture
Osler

Library

Guidelines
Medicines
Articles
Calculators
Explore decks
Institutions
Blog

Prognia

About
Pricing
Contact

Support us

Founders Wall

© 2026 Prognia · Amsterdam, the NetherlandsPrivacy TermsExchangeRate-API

Medicines · US (FDA)

FDA 2019

FDA

Roflumilast

Approved 22 Mar 2019OralTablet

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 500MCG

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 · TabletThis page
ROFLUMILAST 250MCG · Tablet

At a glance

Brand name: Roflumilast
Route: Oral
Dosage form: Tablet
Applicant: Micro Labs
Status: Prescription
FDA approval: 22 Mar 2019
Application: ANDA208180-001

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 · TabletANDA208272-002 · Discontinued

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 ANDA208180.

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.