Application 020800

Type: NDA
Sponsor: IMPAX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TWINJECT 0.3	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	No	No
002	TWINJECT 0.15	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	No	No
003	ADRENACLICK	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	Yes	Yes
004	ADRENACLICK	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020800-001	TWINJECT	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30
N020800-002	TWINJECT	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28
N020800-003	ADRENACLICK	EPINEPHRINE	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25
N020800-004	ADRENACLICK	EPINEPHRINE	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020800-003	BX
N020800-004	BX

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 · 164 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
2026-02-19 14:30 UTC	2026-02	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020800-001	TWINJECT	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-002	TWINJECT	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020800-001	TWINJECT 0.3	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2003-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-002	TWINJECT 0.15	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS			2004-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-003	ADRENACLICK	EQ 0.15MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-004	ADRENACLICK	EQ 0.3MG/DELIVERY	INJECTABLE / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2009-11-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020800-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020800-004	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020800-004	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020800-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020800-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020800-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020800-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020800-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020800-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020800-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020800-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020800-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020800-004	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020800-003	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020800-004	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020800-003	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020800-004	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020800-003	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020800-004	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020800-003	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020800-004	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020800-003	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020800-003	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020800-003	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-004	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020800-003	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020800-003	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020800-004	BX	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 182 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-001	7297136	2025-01-18	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-001	7621891	2025-02-04	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-002	7297136	2025-01-18	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-002	7621891	2025-02-04	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020800-001	7297136	2025-01-18	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-001	7621891	2025-02-04	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-002	7297136	2025-01-18	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-002	7621891	2025-02-04	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020800-001	7297136	2025-01-18	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-001	7621891	2025-02-04	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-002	7297136	2025-01-18	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-002	7621891	2025-02-04	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020800-001	7297136	2025-01-18	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-001	7621891	2025-02-04	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-002	7297136	2025-01-18	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-002	7621891	2025-02-04	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020800-001	7297136	2025-01-18	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-001	7621891	2025-02-04	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-002	7297136	2025-01-18	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-002	7621891	2025-02-04	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-003	10166334	2025-01-21	Drug product	2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-003	7905352	2027-04-12	Drug product	2017-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	10166334	2025-01-21	Drug product	2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020800-004	7905352	2027-04-12	Drug product	2017-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020800-001	7297136	2025-01-18	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020800-001	7621891	2025-02-04	Drug product		`782e0a99824c…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
epinephrine	EPINEPHRINE	REMEDYREPACK INC.	c66de0d3-3b0f-4e52-a712-60357a107676	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800 ndc (product): 70518-2048
epinephrine	EPINEPHRINE	Amneal Pharmaceuticals of New York LLC	e13f05f1-7d21-49bb-b8d5-24bf9301c3d7	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800 ndc (product): 0115-1695 ndc (product): 0115-1694
epinephrine	EPINEPHRINE	REMEDYREPACK INC.	bfc7ab3d-1e0e-4fd9-b6df-09603eb5808c	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	Sportpharm LLC	e7798493-9407-4a5d-9c90-0cc336c59ec1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine Pediatrics	EPINEPHRINE 0.15 PEDIATRICS	Sina Health Inc	287930f8-c5c6-56bd-e063-6394a90ad32e	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine 0.3 Adults	EPINEPHRINE 0.3 ADULTS	Sina Health Inc	28642ad9-b839-ce3a-e063-6394a90ab866	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	A-S Medication Solutions	a5134e63-9a31-4573-826f-b442d069b3e6	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800 ndc (product): 50090-3155
epinephrine	EPINEPHRINE	ASCLEMED USA INC.	76f65a94-4b26-4c40-8a74-79a73afbb4e2	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
Epinephrine	EPINEPHRINE	Advanced Rx Pharmacy of Tennessee, LLC	f4d7aca4-0acd-74c2-e053-2995a90a9d94	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
epinephrine	EPINEPHRINE	Asclemed USA, Inc.	0a29fe62-e241-4272-b91c-c1036b031cd4	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	75dbc3f5-9caf-9f55-e053-2a91aa0a4719	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020800 application number: NDA020800 ndc (product): 51662-1222 ndc (product): 51662-1223

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
21695-947	epinephrine	epinephrine	Rebel Distributors Corp	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
50090-1360	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4506	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
68788-6376	epinephrine	epinephrine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
70385-2009	epinephrine	epinephrine	Sina Health Inc	NDA AUTHORIZED GENERIC	Current
70385-2017	epinephrine	epinephrine	Sina Health Inc	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71872-7007	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7007	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7103	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7103	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85501	SUPPL	2026-03-24
85444	SUPPL	2026-03-23
80264	SUPPL	2024-11-21
80251	SUPPL	2024-11-20
66119	SUPPL	2021-02-08
66113	SUPPL	2021-02-05
55473	SUPPL	2018-09-13
55369	SUPPL	2018-08-30
47090	SUPPL	2017-02-02
13460	SUPPL	2016-05-20
25867	SUPPL	2016-05-19
3391	SUPPL	2014-10-22
35387	SUPPL	2014-10-21
35386	SUPPL	2014-07-29
25866	SUPPL	2014-07-28
13459	SUPPL	2014-04-25
25865	SUPPL	2014-04-24
20967	SUPPL	2013-10-21
25864	SUPPL	2011-02-03
13458	SUPPL	2011-01-31
35385	SUPPL	2009-12-02
25863	SUPPL	2007-01-08
25861	SUPPL	2005-07-15
25862	SUPPL	2005-07-08
41709	ORIG	2005-04-08
3390	SUPPL	2005-02-23
3389	SUPPL	2004-06-01
3388	ORIG	2003-06-08