Application 201739

Type: NDA
Sponsor: KALEO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	Yes	No
002	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	Yes	Yes
003	AUVI-Q	EPINEPHRINE	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.1MG/DELIVERY	Yes	No

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

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	RLD / RS	Approval date
N201739-001	AUVI-Q	EPINEPHRINE	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10
N201739-002	AUVI-Q	EPINEPHRINE	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10
N201739-003	AUVI-Q	EPINEPHRINE	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N201739-001	BX
N201739-002	BX

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201739-001	11590286	2026-12-12		Drug product	2023-03-29
N201739-001	8206360	2027-02-27		Drug product	2013-03-21
N201739-001	7947017	2028-03-12		Drug product	2013-02-22
N201739-001	8231573	2028-11-25		Drug product	2012-08-21
N201739-001	8226610	2029-04-10		Drug product	2012-08-21
N201739-001	8021344	2029-11-02		Drug product	2013-07-26
N201739-002	11590286	2026-12-12		Drug product	2023-03-29
N201739-002	8206360	2027-02-27		Drug product
N201739-002	7947017	2028-03-12		Drug product
N201739-002	8231573	2028-11-25		Drug product
N201739-002	8226610	2029-04-10		Drug product
N201739-002	8021344	2029-11-02		Drug product	2013-07-26
N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04
N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10
N201739-002	11771830	2037-12-21	U-2980	Drug product	2023-12-20
N201739-003	11590286	2026-12-12		Drug product	2023-03-29
N201739-003	8206360	2027-02-27		Drug product	2017-12-15
N201739-003	7947017	2028-03-12		Drug product	2017-12-15
N201739-003	8231573	2028-11-25		Drug product	2017-12-15
N201739-003	8226610	2029-04-10		Drug product	2017-12-15
N201739-003	8021344	2029-11-02		Drug product	2017-12-15
N201739-003	10688244	2037-12-21	U-2980	Drug product	2020-11-04
N201739-003	10842938	2037-12-21	U-2980	Drug product	2020-12-10
N201739-003	11771830	2037-12-21	U-2980	Drug product	2023-12-20

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 4 · 123 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	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-002	AUVI-Q	EQ 0.15MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD, RS	2012-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-003	AUVI-Q	EQ 0.1MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS		RLD	2017-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201739-001	AUVI-Q	EQ 0.3MG/DELIVERY	SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS	BX	RLD	2012-08-10	`8072bd15b7f6…`

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	N201739-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201739-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201739-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201739-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201739-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201739-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201739-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201739-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201739-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201739-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201739-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201739-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201739-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-001	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201739-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201739-001	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201739-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201739-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201739-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201739-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N201739-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201739-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N201739-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201739-001	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201739-002	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201739-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201739-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201739-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201739-002	BX	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 69 · 2,725 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201739-001	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8206360	2027-02-27		Drug product	2013-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	7947017	2028-03-12		Drug product	2013-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8231573	2028-11-25		Drug product	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8226610	2029-04-10		Drug product	2012-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-001	8021344	2029-11-02		Drug product	2013-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8206360	2027-02-27		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	7947017	2028-03-12		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8231573	2028-11-25		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8226610	2029-04-10		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	8021344	2029-11-02		Drug product	2013-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-002	11771830	2037-12-21	U-2980	Drug product	2023-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	11590286	2026-12-12		Drug product	2023-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8206360	2027-02-27		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	7947017	2028-03-12		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8231573	2028-11-25		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8226610	2029-04-10		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	8021344	2029-11-02		Drug product	2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201739-003	11771830	2037-12-21	U-2980	Drug product	2023-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	10335549	2025-04-30		Drug product	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	11590286	2026-12-12		Drug product	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8206360	2027-02-27		Drug product	2013-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	7947017	2028-03-12		Drug product	2013-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8231573	2028-11-25		Drug product	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8226610	2029-04-10		Drug product	2012-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-001	8021344	2029-11-02		Drug product	2013-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10335549	2025-04-30		Drug product	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	11590286	2026-12-12		Drug product	2023-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8206360	2027-02-27		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	7947017	2028-03-12		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8231573	2028-11-25		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8226610	2029-04-10		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	8021344	2029-11-02		Drug product	2013-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10688244	2037-12-21	U-2980	Drug product	2020-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201739-002	10842938	2037-12-21	U-2980	Drug product	2020-12-10	`31067a03dcf5…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Auvi-Q	EPINEPHRINE	kaleo, Inc	6180fb40-7fca-4602-b3da-ce62b8cd2470	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 60842-023 ndc (product): 60842-021 ndc (product): 60842-022
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23e772f8-26d0-b516-e063-6394a90ada58	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	296a9023-b5c6-6102-e063-6294a90af87e	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	29299266-69c5-b1a7-e063-6394a90a25f8	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23fd4c93-0a42-922e-e063-6394a90a1887	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
AUVI-Q	AUVI-Q	HF Acquisition Co LLC, DBA HealthFirst	23fdb616-0c60-44fe-e063-6394a90ad8f1	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	98aaa648-fc25-754d-e053-2995a90a7051	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 51662-1476
EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	7664bb0d-dc1a-ca8b-e053-2991aa0ad627	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 51662-1320 ndc (product): 51662-1321
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f110633-bf37-458d-e053-2a95a90a8fa9	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 71872-7173
Auvi-Q	EPINEPHRINE	Medical Purchasing Solutions, LLC	8f00231e-be88-49fe-e053-2a95a90ab6dd	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201739 application number: NDA201739 ndc (product): 71872-7172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1320	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1321	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1476	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-021	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-022	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
60842-023	Auvi-Q	epinephrine	kaleo, Inc	NDA	Current
71872-7172	Auvi-Q	epinephrine	Medical Purchasing Solutions, LLC	NDA	Current
71872-7173	Auvi-Q	epinephrine	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82141	SUPPL	2025-05-05
82286	SUPPL	2025-04-30
77674	SUPPL	2024-02-29
77659	SUPPL	2024-02-29
60183	SUPPL	2019-10-01
60168	SUPPL	2019-10-01
50458	SUPPL	2017-11-17
50457	SUPPL	2017-11-17
50456	SUPPL	2017-11-17
50455	SUPPL	2017-11-17
47296	SUPPL	2017-02-23
47091	SUPPL	2017-02-02
40084	SUPPL	2016-05-20
32133	SUPPL	2016-05-19
43373	ORIG	2012-12-04
19033	ORIG	2012-08-15
32132	ORIG	2012-08-14
52479	ORIG	1900-01-01