Application 019430

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPIPEN	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.3MG/DELIVERY	Yes	Yes
002	EPIPEN JR.	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.15MG/DELIVERY	Yes	Yes
003	EPIPEN E Z PEN	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR	0.3MG/DELIVERY	No	No
004	EPI E Z PEN JR	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR	0.15MG/DELIVERY	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019430-001	EPIPEN	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22
N019430-002	EPIPEN JR.	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22
N019430-003	EPIPEN E Z PEN	EPINEPHRINE	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03
N019430-004	EPI E Z PEN JR	EPINEPHRINE	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019430-001	AB
N019430-002	AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-001	EPIPEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-002	EPIPEN JR.	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	AB	RLD, RS	1987-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-003	EPIPEN E Z PEN	0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019430-004	EPI E Z PEN JR	0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR			1995-08-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N019430-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019430-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019430-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019430-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019430-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019430-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019430-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019430-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019430-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019430-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019430-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019430-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019430-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019430-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019430-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019430-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019430-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019430-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019430-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019430-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019430-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019430-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019430-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019430-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019430-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019430-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019430-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019430-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019430-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019430-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019430-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019430-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019430-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019430-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019430-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019430-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019430-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019430-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019430-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019430-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	7449012	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	7794432	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	7449012	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	7794432	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	8048035	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019430-001	7449012	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	7794432	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	7449012	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	7794432	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	8048035	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	7449012	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	7794432	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	7449012	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	7794432	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	8048035	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	7449012	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	7794432	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	8048035	2025-09-11	Drug product	2011-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	8870827	2025-09-11	Drug product	2014-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-001	9586010	2025-09-11	Drug product	2017-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	7449012	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	7794432	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	8048035	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	8870827	2025-09-11	Drug product	2014-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019430-002	9586010	2025-09-11	Drug product	2017-05-12	`b8a1b40f171c…`

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epinephrine 0.3 Adults	EPINEPHRINE 0.3 ADULTS	Sina Health Inc	2865e9a5-1228-e2bc-e063-6394a90af94e	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine 0.15 Pediatrics	EPINEPHRINE 0.15 PEDIATRICS	Sina Health Inc	28649bcc-648c-c977-e063-6394a90a0b2b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	A-S Medication Solutions	b7a4171c-7934-4723-a140-bd93ea84aae1	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 50090-4543
EPIPEN	EPINEPHRINE	Asclemed USA, Inc.	311af6d9-20c0-4b87-b236-4185bfa49988	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 71872-7135
Epinephrine	EPINEPHRINE	Medical Purchasing Solutions, LLC	6bdca08a-65bf-f56c-e053-2a91aa0a56d8	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 71872-7134
EPIPEN	EPINEPHRINE	Viatris Specialty LLC	7560c201-9246-487c-a13b-6295db04274a	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 49502-500 ndc (product): 49502-501
Epinephrine	EPINEPHRINE	Viatris Specialty LLC	778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 49502-101 ndc (product): 49502-102
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75e96faa-545b-52d6-e053-2991aa0a8fb8	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019430 application number: NDA019430 ndc (product): 51662-1225 ndc (product): 51662-1224

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 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-101	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-102	Epinephrine	Epinephrine	Mylan Specialty L.P.	NDA AUTHORIZED GENERIC	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-500	EPIPEN	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
49502-501	EPIPEN JR	epinephrine	Mylan Specialty L.P.	NDA	Current
50090-1243	EPIPEN JR	epinephrine	A-S Medication Solutions	NDA	Current
50090-2733	Epinephrine	Epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2734	Epinephrine	Epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4543	Epinephrine	Epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4543	Epinephrine	Epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
51662-1224	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1224	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1224	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1224	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1225	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1225	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1225	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1225	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
55045-3207	EpiPen	Epinephrine	Dispensing Solutions, Inc.	NDA	Current
55045-3598	EpiPen Jr	Epinephrine	Dispensing Solutions, Inc.	NDA	Current
64725-0500	EPIPEN	epinephrine	TYA Pharmaceuticals	NDA	Current
64725-0501	EPIPEN JR	epinephrine	TYA Pharmaceuticals	NDA	Current
70518-1224	EPIPEN	epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1224	EPIPEN	epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1224	EPIPEN	epinephrine	REMEDYREPACK INC.	NDA	Current
70518-1224	EPIPEN	epinephrine	REMEDYREPACK INC.	NDA	Current
71872-7134	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7134	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7135	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7135	Epinephrine	Epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85502	SUPPL	2026-03-24
85440	SUPPL	2026-03-23
73478	SUPPL	2023-02-13
73456	SUPPL	2023-02-13
65775	SUPPL	2020-12-29
65771	SUPPL	2020-12-28
63643	SUPPL	2020-06-19
63607	SUPPL	2020-06-18
61761	SUPPL	2020-02-04
61757	SUPPL	2020-02-03
57200	SUPPL	2019-01-14
55309	SUPPL	2018-08-24
55293	SUPPL	2018-08-24
52646	SUPPL	2018-02-14
50605	SUPPL	2017-12-06
48229	SUPPL	2017-05-03
48199	SUPPL	2017-05-02
47089	SUPPL	2017-02-02
33746	SUPPL	2016-05-20
17399	SUPPL	2016-05-20
33744	SUPPL	2014-07-30
1323	SUPPL	2014-07-21
33745	SUPPL	2014-05-02
17398	SUPPL	2014-05-01
40912	SUPPL	2014-01-16
20240	SUPPL	2014-01-16
40911	SUPPL	2014-01-15
17397	SUPPL	2012-08-22
11505	SUPPL	2012-08-20
17396	SUPPL	2009-05-26
11504	SUPPL	2008-10-03
17395	SUPPL	2008-10-01
17394	SUPPL	2003-12-22
33743	SUPPL	2003-04-15