Application 012102

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEDIHALER ERGOTAMINEERGOTAMINE TARTRATEAEROSOL, METERED;INHALATION0.36MG/INHNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N012102-001MEDIHALER ERGOTAMINEERGOTAMINE TARTRATE0.36MG/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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N012102-001MEDIHALER ERGOTAMINE0.36MG/INHAEROSOL, METERED / INHALATIONApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ergomar SublingualERGOTAMINE TARTRATEPangea Pharmaceuticals LLCa9582fdb-7ddd-4f69-aa7a-66247cdb8c922025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ERGOTAMINE TARTRATE