Application 207534

Type: NDA
Sponsor: ADAMIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMJEPI	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	0.3MG/0.3ML (0.3MG/0.3ML)	Yes	Yes
002	SYMJEPI	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	0.15MG/0.3ML (0.15MG/0.3ML)	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
N207534-001	SYMJEPI	EPINEPHRINE	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD, RS	2017-06-15
N207534-002	SYMJEPI	EPINEPHRINE	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2018-09-27

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16
N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16

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.

Product history page 1 of 3 · 86 observed 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	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207534-001	SYMJEPI	0.3MG/0.3ML (0.3MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2017-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207534-002	SYMJEPI	0.15MG/0.3ML (0.15MG/0.3ML)	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	RLD, RS	2018-09-27	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207534-001	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207534-002	11141540	2036-10-20	U-3379	Drug product	2022-06-16	`a72a2bbeb626…`

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 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
epinephrine	EPINEPHRINE	Baxter Healthcare Corporation	60efd409-3555-4182-a68d-1cd7bc0d1bfc	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	Sportpharm LLC	e7798493-9407-4a5d-9c90-0cc336c59ec1	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	REMEDYREPACK INC.	de4916c5-bdc8-4da9-a857-a319882a831a	2026-02-03	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	af10f2bb-b0ad-45a6-b525-e715613350af	2026-01-13	Warnings, Adverse reactions	Name fallback 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 generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	3fd8dd51-0aeb-43dd-9de0-c11b0330b15e	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	BPI Labs, LLC	db18519b-82a9-435b-85c7-a040d644f057	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	BPI Labs, LLC	5b5282a9-b149-4f0a-978e-5adbf48ec8aa	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	GLENMARK PHARMACEUTICALS INC., USA	cc4ebb51-6020-4339-a36a-ec2380b7d28e	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	ProPharma Distribution	384445ac-0696-e367-e063-6394a90a019f	2025-12-18	Warnings, Adverse reactions	Name fallback 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 generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	A-S Medication Solutions	a5134e63-9a31-4573-826f-b442d069b3e6	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	A-S Medication Solutions	ab5e23d0-6e99-4647-838d-23a4040602b5	2025-11-10	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Henry Schein, Inc.	3b1ac82f-6920-4e40-a77e-598398679f2d	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals LLC	c0ef05d5-3fc8-4fb4-bf5b-c219ff17b092	2025-10-31	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	Medical Purchasing Solutions, LLC.	409581e7-ab70-41f3-e063-6294a90a15dc	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Auvi-Q	EPINEPHRINE	kaleo, Inc	6180fb40-7fca-4602-b3da-ce62b8cd2470	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3442	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3442	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3442	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3442	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3442	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3448	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3448	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3448	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
0781-3448	SYMJEPI	Epinephrine	Sandoz Inc.	NDA	Current
38739-200	SYMJEPI	Epinephrine	Adamis Pharmaceuticals Corporation	NDA	Current
78670-130	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-130	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-130	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-130	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-131	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-131	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-131	Symjepi	epinephrine	USWM, LLC	NDA	Current
78670-131	Symjepi	epinephrine	USWM, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67987	SUPPL	2021-06-30
67981	SUPPL	2021-06-30
64424	SUPPL	2020-08-27
55804	SUPPL	2018-10-03
55753	SUPPL	2018-10-01
49517	ORIG	2017-08-23
48731	ORIG	2017-06-16
48725	ORIG	2017-06-15