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 44.

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
2026-10-15 13:18:302026-09N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28c2088c7a36db…
2026-10-15 13:18:302026-09N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16c2088c7a36db…
2026-09-14 22:38:342026-08N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-2884e616aacf4f…
2026-09-14 22:38:342026-08N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-1684e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

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

Documents#

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