FDA.reportPublic FDA data

Application 018040

Type
NDA
Sponsor
JANSSEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONISTATMICONAZOLEINJECTABLE;INJECTION10MG/MLNoNo

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
N018040-001MONISTATMICONAZOLE10MG/MLINJECTABLE / INJECTIONApproved 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 UTC2022-10N018040-001MONISTAT10MG/MLINJECTABLE / INJECTIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018040-001MONISTAT10MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018040-001MONISTAT10MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018040-001MONISTAT10MG/MLINJECTABLE / INJECTIONApproved 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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsName fallback
generic name: MICONAZOLE
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsName fallback
generic name: MICONAZOLE
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsName fallback
generic name: MICONAZOLE
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsName fallback
generic name: MICONAZOLE
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsName fallback
generic name: MICONAZOLE
natouchMICONAZOLENatouch LLCa980ff33-2b6d-3065-e053-2995a90ae9742026-02-11WarningsName fallback
generic name: MICONAZOLE
natouchMICONAZOLENatouch LLC3b1209fc-9d6b-2f55-e063-6394a90ac2ad2026-02-10WarningsName fallback
generic name: MICONAZOLE
OravigMICONAZOLEGalt Pharmaceuticals, LLCdc2427ff-e566-4b48-b289-9e51c011250a2026-01-08Warnings, Adverse reactionsName fallback
generic name: MICONAZOLE
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsName fallback
generic name: MICONAZOLE

Reported adverse events (FAERS/openFDA)#

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