FDA.reportPublic FDA data

Application 010375

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003MEDIHALER-ISOISOPROTERENOL SULFATEAEROSOL, METERED;INHALATION0.08MG/INHNoNo
004ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEAEROSOL, METERED;INHALATION0.12MG/INHNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010375-003MEDIHALER-ISOISOPROTERENOL SULFATE0.08MG/INHAEROSOL, METERED / INHALATIONApproved before 1982
N010375-004ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.12MG/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 22:54:322026-06N010375-003MEDIHALER-ISO0.08MG/INHAEROSOL, METERED / INHALATIONApproved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N010375-004ISOPROTERENOL HYDROCHLORIDE0.12MG/INHAEROSOL, METERED / INHALATIONApproved before 1982a50c72e98297…