FDA.reportPublic FDA data

Application 021279

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORADILFORMOTEROL FUMARATEPOWDER; INHALATION0.012MG/INHNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Formoterol FumarateFORMOTEROL FUMARATEAlembic Pharmaceuticals Inc.07afdf7e-c480-4806-b469-a6a460522bc02025-12-23Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol FumarateFORMOTEROL FUMARATEIngenus Pharmaceuticals, LLC303479a7-80fb-1f6d-e063-6394a90abbda2025-06-05Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol FumarateFORMOTEROL FUMARATEDr. Reddy's Laboratories Inc.2010b5cb-c277-57dd-ed6b-607cad2c45a42025-01-30Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
formoterol fumarateFORMOTEROL FUMARATELupin Pharmaceuticals, Inc.44284e8c-0503-48c4-ae71-a0d6b865665d2025-01-13Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol fumarateFORMOTEROL FUMARATEMicro Labs Limited0796acea-70d6-479f-af48-18723b1efd2a2024-09-26Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol fumarateFORMOTEROL FUMARATEBryant Ranch Prepackd8f7c5ff-bd3c-4eab-b58a-1e3a478e58792024-01-11Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol fumarateFORMOTEROL FUMARATEBryant Ranch Prepack9786f3e2-4265-4246-9999-f73cd6b33fc82024-01-11Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE
Formoterol fumarateFORMOTEROL FUMARATETeva Pharmaceuticals USA, Inc.419bc85d-8e24-478b-921e-babfb73e79f32020-10-31Warnings, Adverse reactionsName fallback
generic name: FORMOTEROL FUMARATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42072ORIG2005-12-16
36557ORIG2004-06-04
44111ORIG2003-12-09
27347ORIG2003-07-23