DULERA — FDA application NDA022518
Listed sponsor: ORGANON LLC · OGN company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED | INHALATION | 0.005MG/INH;0.1MG/INH | Prescription | not listed | Yes |
| 002 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED | INHALATION | 0.005MG/INH;0.2MG/INH | Prescription | not listed | Yes |
| 003 | DULERA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED | INHALATION | 0.005MG/INH;0.05MG/INH | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
No Orange Book patent or exclusivity listings joined to this application.
Compound cross-links
- FORMOTEROL FUMARATE · UNII W34SHF8J2K · no lmmol compound match
- MOMETASONE FUROATE · UNII 04201GDN4R · lmmol compound WOFMFGQZHJDGCX-ZULDAHANSA-N · CHEMBL1161
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.