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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
epinephrine	EPINEPHRINE	Sportpharm LLC	e7798493-9407-4a5d-9c90-0cc336c59ec1	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	REMEDYREPACK INC.	de4916c5-bdc8-4da9-a857-a319882a831a	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	af10f2bb-b0ad-45a6-b525-e715613350af	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Adrenalin Vials	EPINEPHRINE	Sina Health Inc	28649937-8ae1-a022-e063-6394a90aebe0	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine 1553	EPINEPHRINE	Professional Complementary Health Formulas	c06d262b-b97e-4921-b927-c51e1b27691e	2026-01-08	Warnings	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	7499cbca-b8fe-4fc3-a318-13859ab989a7	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	db18519b-82a9-435b-85c7-a040d644f057	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	BPI Labs, LLC	5b5282a9-b149-4f0a-978e-5adbf48ec8aa	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	ProPharma Distribution	384445ac-0696-e367-e063-6394a90a019f	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Adrenalin	EPINEPHRINE	ProPharma Distribution	3eef2920-0129-6dc2-e063-6294a90ac22a	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	GLENMARK PHARMACEUTICALS INC., USA	01fd19cd-190c-4989-b733-60ba95941297	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	A-S Medication Solutions	a5134e63-9a31-4573-826f-b442d069b3e6	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	A-S Medication Solutions	ab5e23d0-6e99-4647-838d-23a4040602b5	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals LLC	c0ef05d5-3fc8-4fb4-bf5b-c219ff17b092	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Medical Purchasing Solutions, LLC.	409581e7-ab70-41f3-e063-6294a90a15dc	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: EPINEPHRINE generic name: EPINEPHRINE
Auvi-Q	EPINEPHRINE	kaleo, Inc	6180fb40-7fca-4602-b3da-ce62b8cd2470	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	ASCLEMED USA INC.	76f65a94-4b26-4c40-8a74-79a73afbb4e2	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Redpharm Drug	300ac735-4493-c02a-e063-6294a90a5bce	2025-08-30	Warnings, Adverse reactions	Name fallback brand name: Epinephrine generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	ProPharma Distribution	3d728e53-92c2-114e-e063-6394a90ad404	2025-08-28	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