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Active ingredient

Formoterol

14 finished FDA listings contain Formoterol as their only active ingredient; 24 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
FORMOTEROL, FORMOTEROL FUMARATE
Dosage forms
Solution
Routes
Respiratory (Inhalation)
Manufacturers / labelers
13
Strengths listed
.02 mg/2ml · 20 ug/2ml
Brand names in FDA listings
Formoterol Fumarate, Formoterol Fumarate Inhalation Solution, Perforomist

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 25255

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 022007VIATRIS SPECIALTY2007-05-112
ANDA 091141TEVA PHARMS USA INC2021-06-223
ANDA 215078ALEMBIC2021-11-221
ANDA 215053LUPIN2022-08-221
ANDA 216486RITEDOSE CORP2022-11-251
ANDA 215883MANKIND PHARMA2023-03-222
ANDA 218304MICRO LABS2024-06-261
ANDA 216426LEXENPHARM2024-10-221
ANDA 215907DR REDDYS2025-01-301
ANDA 218308DEVA HOLDING AS2025-02-111

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

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