FDA.reportPublic FDA data

Application 017559

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROVENTILALBUTEROLAEROSOL, METERED;INHALATION0.09MG/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
N017559-001PROVENTILALBUTEROL0.09MG/INHAEROSOL, METERED / INHALATIONApproved before 1982

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 UTC2022-10N017559-001PROVENTIL0.09MG/INHAEROSOL, METERED / INHALATIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017559-001PROVENTIL0.09MG/INHAEROSOL, METERED / INHALATIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017559-001PROVENTIL0.09MG/INHAEROSOL, METERED / INHALATIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017559-001PROVENTIL0.09MG/INHAEROSOL, METERED / INHALATIONApproved before 1982a50c72e98297…

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
AlbuterolALBUTEROLAmneal Pharmaceuticals NY LLC230d66fc-f62c-42a6-adb3-0a0f879c8ad42026-04-14Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLMylan Pharmaceuticals Inc.9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62026-03-15Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLBryant Ranch Prepack601a18ed-d66e-498f-a804-f1a3330827d42025-04-21Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLRising Pharma Holdings, Inc.40f3cdbc-c9ee-4a3c-8061-a44b9a1d035c2025-03-06Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLZydus Lifesciences Limiteda4709eea-e4a2-46e2-850f-1e6afca018932024-11-25Name fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLZydus Pharmaceuticals USA Inc.c3fa0068-fd12-45de-818e-e929fb45ba052023-08-21Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLAurobindo Pharma Limitedff9b287b-e4a4-4c12-ad2f-6b7d55b20dc62022-12-15Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL
AlbuterolALBUTEROLProficient Rx LP895dff1c-d21c-4470-b021-a5b68364c1ec2022-04-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
643SUPPL2006-09-18
40751SUPPL1998-11-09