Skip to content
LookupMeds

Active ingredient

Roflumilast

33 finished FDA listings contain Roflumilast as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
ROFLUMILAST
Dosage forms
Aerosol, Foam, Cream, Tablet
Routes
Oral, Topical
Manufacturers / labelers
18
Strengths listed
.5 mg/g · 1.5 mg/g · 250 ug/1 · 3 mg/g · 500 ug/1
Brand names in FDA listings
Daliresp, Zoryve

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1091836

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022522ASTRAZENECA2011-02-282
ANDA 208236SENORES PHARMS2018-10-034
ANDA 208213HETERO LABS LTD III2018-11-233
ANDA 208180MICRO LABS2019-03-223
ANDA 208247STRIDES PHARMA2020-03-302
ANDA 208303ZYDUS PHARMS2022-02-104
ANDA 208299PRINSTON INC2022-05-101
NDA 215985ARCUTIS2022-07-293
ANDA 208256MSN2022-09-075
ANDA 213298AUROBINDO PHARMA LTD2023-04-172
ANDA 212490ALKEM LABS LTD2023-04-183
NDA 217242ARCUTIS2023-12-151

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.