Application 220626

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	1MG/ML (1MG/ML)	Yes	Yes
002	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	30MG/30ML (1MG/ML)	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N220626-001	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2026-03-30
N220626-002	EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2026-03-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220626-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220626-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220626-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220626-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220626-001	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220626-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2026-03-30	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
epinephrine	EPINEPHRINE	Baxter Healthcare Corporation	ef556382-9d19-4f0e-9dbe-fcecc772a3e2	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220626 application number: NDA220626

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85614	ORIG	2026-03-31