FDA.reportPublic FDA data

Application 021592

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORADIL CERTIHALERFORMOTEROL FUMARATEPOWDER;INHALATION0.0085MG/INHNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021592-001FORADIL CERTIHALERFORMOTEROL FUMARATE0.0085MG/INHPOWDER / INHALATION2006-12-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021592-001FORADIL CERTIHALER0.0085MG/INHPOWDER / INHALATION2006-12-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021592-001FORADIL CERTIHALER0.0085MG/INHPOWDER / INHALATION2006-12-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021592-001FORADIL CERTIHALER0.0085MG/INHPOWDER / INHALATION2006-12-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021592-001FORADIL CERTIHALER0.0085MG/INHPOWDER / INHALATION2006-12-15a50c72e98297…

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 · 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
5816SUPPL2010-06-03
15846SUPPL2010-06-02
21752ORIG2008-11-25
23287ORIG2007-02-20
28213ORIG2006-12-28
37308ORIG2006-12-26