Application 218208

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218208-001	EPINEPHRINE	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP		2025-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A218208-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A218208-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218208-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218208-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-12-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218208-001	EPINEPHRINE	EQ 1MG BASE/ML (EQ 1MG BASE/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-12-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218208-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218208-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218208-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218208-001	AP	1	`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	Amneal Pharmaceuticals Private Limited	33fa2443-5c80-4967-98bb-f60d3144421c	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218208 application number: ANDA218208