FDA.reportPublic FDA data

Application 087907

Type
ANDA
Sponsor
ARMSTRONG PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINEPHRINEEPINEPHRINEAEROSOL, METERED;INHALATION0.2MG/INHNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A087907-001EPINEPHRINEEPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087907-001EPINEPHRINE0.2MG/INHAEROSOL, METERED / INHALATION1984-05-23a50c72e98297…

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 4 · 79 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.55befbe4-c819-4367-bbe7-de5841786aac2026-09-03Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.5ba14408-c8fb-4734-aad9-ee19696acac22026-08-28Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5725a519-3ad6-7e5e-e063-6394a90a111f2026-08-10Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5726eeca-db88-ba8e-e063-6294a90a927d2026-08-03Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLCa6afb9e8-1db9-480c-8d31-58c5c870ca492026-07-29Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLC4f83895f-638c-4515-af03-7c41ae60a42e2026-07-15Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEA-S Medication Solutions6e811e28-0199-4df7-a916-5940c632401d2026-07-13Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EPINEPHRINEEPINEPHRINECIVICA, INC.4a79ad00-405b-4454-a692-7f1daac4adec2026-07-10Warnings, Adverse reactionsName fallback
brand name: EPINEPHRINE
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEA-S Medication Solutions386519ba-7a44-4edd-9eb1-748419b7a71b2026-07-06Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLC3b7a4364-668d-4eb2-a20c-04adc35aabe42026-07-01Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEREMEDYREPACK INC.0172280c-f7d6-4613-9dbd-f94d3ae5825a2026-06-08Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINEHikma Pharmaceuticals USA Inc.1e8ebac1-5b32-47f9-a930-86a98a24dccc2026-05-05Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
EpinephrineEPINEPHRINESportpharm LLC3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92026-04-24Warnings, Adverse reactionsName fallback
brand name: Epinephrine
generic name: EPINEPHRINE
neffyEPINEPHRINESportpharm LLC2052f9db-7d76-443b-b702-b6b499f9a4b82026-04-24Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
neffyEPINEPHRINEARS Pharmaceuticals Operations, Inc.a1758142-a905-401d-8961-05829f51023a2026-04-09Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLCa5ce0c01-dd47-4997-ab09-490de65d38352026-04-08Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
AdrenalinEPINEPHRINEPar Health USA, LLCb27e06aa-5b40-44bc-8de7-80b027580a3b2026-04-08Warnings, Adverse reactionsName fallback
generic name: EPINEPHRINE
epinephrineEPINEPHRINEBaxter Healthcare Corporationef556382-9d19-4f0e-9dbe-fcecc772a3e22026-03-30Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE
epinephrineEPINEPHRINEREMEDYREPACK INC.c66de0d3-3b0f-4e52-a712-60357a1076762026-03-24Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE
epinephrineEPINEPHRINEAmneal Pharmaceuticals of New York LLCe13f05f1-7d21-49bb-b8d5-24bf9301c3d72026-03-20Warnings, Adverse reactionsName fallback
brand name: epinephrine
generic name: EPINEPHRINE

Reported adverse events (FAERS/openFDA)#

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