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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPIPEN	EPINEPHRINE	Asclemed USA, Inc.	311af6d9-20c0-4b87-b236-4185bfa49988	2023-08-29	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Adrenalinum	EPINEPHRINE	Boiron	84b2e61b-7c92-5a2e-e053-2a91aa0a626c	2023-07-12		Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bdca08a-65bf-f56c-e053-2a91aa0a56d8	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Adrenalin	EPINEPHRINE	Medical Purchasing Solutions, LLC	b622a9b9-2f09-46e4-e053-2995a90aae01	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Medical Purchasing Solutions, LLC	c4327095-3a89-d86a-e053-2a95a90ac255	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f110633-bf37-458d-e053-2a95a90a8fa9	2023-04-26	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f00231e-be88-49fe-e053-2a95a90ab6dd	2023-04-26	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	American Regent, Inc.	61cacda5-64ee-45ca-b94c-e8640c43e581	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
EPIPEN	EPINEPHRINE	Viatris Specialty LLC	7560c201-9246-487c-a13b-6295db04274a	2023-02-15	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Viatris Specialty LLC	778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836	2023-02-15	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75dbc3f5-9caf-9f55-e053-2a91aa0a4719	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75e96faa-545b-52d6-e053-2991aa0a8fb8	2022-12-09	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	677c33a2-4e16-406e-e053-2991aa0a4594	2022-10-13	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Asclemed USA, Inc.	099bc72c-8ffe-4b8c-9608-044c864982fb	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Teva Pharmaceuticals USA, Inc.	04f07f15-55e2-411b-abb8-07eab37f5664	2021-01-31	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