Application 219239

Type: ANDA
Sponsor: GLAND

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10MG/10ML (1MG/ML)	No	No
002	EPINEPHRINE	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	30MG/30ML (1MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A219239-001	EPINEPHRINE	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06
A219239-002	EPINEPHRINE	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02
A219239-003	EPINEPHRINE	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2026-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A219239-001	AP
A219239-002	AP
A219239-003	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
2026-11-14 07:37:17	2026-10	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A219239-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2026-09-22	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A219239-003	EPINEPHRINE	1MG/ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2026-09-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS	AP	2025-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS	AP	2025-02-06	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219239-001	EPINEPHRINE	10MG/10ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-02-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219239-002	EPINEPHRINE	30MG/30ML (1MG/ML)	SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	AP	2025-10-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A219239-001	AP	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A219239-002	AP	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A219239-003	AP	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A219239-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A219239-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A219239-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A219239-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A219239-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A219239-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A219239-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219239-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219239-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219239-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219239-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219239-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A219239-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A219239-001	AP	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219239-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219239-002	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219239-001	CGT	2025-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219239-001	CGT	2025-09-03	`6a471c1ec25d…`

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 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPINEPHRINE	EPINEPHRINE	REMEDYREPACK INC.	55befbe4-c819-4367-bbe7-de5841786aac	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	REMEDYREPACK INC.	5ba14408-c8fb-4734-aad9-ee19696acac2	2026-08-28	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	5725a519-3ad6-7e5e-e063-6394a90a111f	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	5726eeca-db88-ba8e-e063-6294a90a927d	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Fresenius Kabi USA, LLC	a6afb9e8-1db9-480c-8d31-58c5c870ca49	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Fresenius Kabi USA, LLC	4f83895f-638c-4515-af03-7c41ae60a42e	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	A-S Medication Solutions	6e811e28-0199-4df7-a916-5940c632401d	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	CIVICA, INC.	4a79ad00-405b-4454-a692-7f1daac4adec	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	A-S Medication Solutions	386519ba-7a44-4edd-9eb1-748419b7a71b	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Adrenalin	EPINEPHRINE	Par Health USA, LLC	3b7a4364-668d-4eb2-a20c-04adc35aabe4	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	REMEDYREPACK INC.	0172280c-f7d6-4613-9dbd-f94d3ae5825a	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Hikma Pharmaceuticals USA Inc.	1e8ebac1-5b32-47f9-a930-86a98a24dccc	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Sportpharm LLC	3a8f5ca2-6c1d-4011-9266-ba93c7a3abb9	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
neffy	EPINEPHRINE	Sportpharm LLC	2052f9db-7d76-443b-b702-b6b499f9a4b8	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
neffy	EPINEPHRINE	ARS Pharmaceuticals Operations, Inc.	a1758142-a905-401d-8961-05829f51023a	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Adrenalin	EPINEPHRINE	Par Health USA, LLC	a5ce0c01-dd47-4997-ab09-490de65d3835	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Adrenalin	EPINEPHRINE	Par Health USA, LLC	b27e06aa-5b40-44bc-8de7-80b027580a3b	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	Baxter Healthcare Corporation	ef556382-9d19-4f0e-9dbe-fcecc772a3e2	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	REMEDYREPACK INC.	c66de0d3-3b0f-4e52-a712-60357a107676	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals of New York LLC	e13f05f1-7d21-49bb-b8d5-24bf9301c3d7	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE

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
81472	ORIG	2025-03-06