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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	093312af-6eed-1f4b-e063-6294a90a155d	2023-11-02	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
epinephrine	EPINEPHRINE	American Regent, Inc.	6add7604-71f6-4d8a-9447-17ad01fa839d	2023-10-01	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
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 generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bdca08a-65bf-f56c-e053-2a91aa0a56d8	2023-05-22	Warnings, Adverse reactions	Name fallback 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 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 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 generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75dbc3f5-9caf-9f55-e053-2a91aa0a4719	2022-12-09	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75e96faa-545b-52d6-e053-2991aa0a8fb8	2022-12-09	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	677c33a2-4e16-406e-e053-2991aa0a4594	2022-10-13	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Asclemed USA, Inc.	099bc72c-8ffe-4b8c-9608-044c864982fb	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: EPINEPHRINE
Epinephrine	EPINEPHRINE	Teva Pharmaceuticals USA, Inc.	04f07f15-55e2-411b-abb8-07eab37f5664	2021-01-31	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