FDA.reportPublic FDA data

Application 218475

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATESOLUTION;INTRAVENOUSEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)YesYes
002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATESOLUTION;INTRAVENOUSEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28
N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16

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
2026-08-18 06:07:402026-07N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epinephrineEPINEPHRINEBaxter Healthcare Corporation60efd409-3555-4182-a68d-1cd7bc0d1bfc2026-03-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 218475
application number: NDA218475

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83642SUPPL 2025-10-03
81429ORIG 2025-03-04
81393ORIG 2025-03-03