Application 210134

Type: NDA
Sponsor: ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BAQSIMI	GLUCAGON	POWDER;NASAL	3MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210134-001	BAQSIMI	GLUCAGON	3MG	POWDER / NASAL		RLD, RS	2019-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23
N210134-001	12370241	2036-02-16	U-2604	Drug product	2025-11-14
N210134-001	10765602	2039-09-23		Drug product	2020-10-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210134-001	NPP	2028-03-17

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210134-001	BAQSIMI	3MG	POWDER / NASAL	RLD, RS	2019-07-24	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 131 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210134-001	12370241	2036-02-16	U-2604	Drug product	2025-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210134-001	12370241	2036-02-16	U-2604	Drug product	2025-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210134-001	12370241	2036-02-16	U-2604	Drug product	2025-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210134-001	10765602	2039-09-23		Drug product	2020-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210134-001	10213487	2036-02-16	U-2604	Drug product	2019-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210134-001	10894133	2038-01-03		Drug product	2021-02-10	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N210134-001	NPP	2028-03-17	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210134-001	NP	2022-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210134-001	NP	2022-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210134-001	NP	2022-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210134-001	NP	2022-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210134-001	NP	2022-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210134-001	NP	2022-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210134-001	NP	2022-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210134-001	NP	2022-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210134-001	NP	2022-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210134-001	NP	2022-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210134-001	NP	2022-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210134-001	NP	2022-07-24	`b00525d2431f…`
2023-01-26 05:58 UTC	2023-01	N210134-001	NP	2022-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210134-001	NP	2022-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210134-001	NP	2022-07-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210134-001	NP	2022-07-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210134-001	NP	2022-07-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210134-001	NPP	2028-03-17	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baqsimi	GLUCAGON	Sportpharm LLC	32ba41fa-4158-40af-8cb2-03693c248994	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210134 application number: NDA210134
Baqsimi	GLUCAGON	Amphastar Pharmaceuticals, Inc.	f1f5df9b-872f-44e5-a18f-f0b68e7e9254	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210134 application number: NDA210134

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-6145	Baqsimi	glucagon	Eli Lilly and Company	NDA	Current
0002-6145	Baqsimi	glucagon	Eli Lilly and Company	NDA	Current
0002-6145	Baqsimi	glucagon	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81633	SUPPL	2025-03-18
81629	SUPPL	2025-03-18
65120	SUPPL	2020-11-02
65066	SUPPL	2020-10-29
61041	ORIG	2019-11-25
59443	ORIG	2019-07-25
59441	ORIG	2019-07-24
63063	ORIG	1900-01-01
63062	ORIG	1900-01-01
63061	ORIG	1900-01-01
63060	ORIG	1900-01-01