Application 207923

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEEBRI	GLYCOPYRROLATE	POWDER;INHALATION	15.6MCG/INH	Yes	No

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

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
N207923-001	SEEBRI NEOHALER	GLYCOPYRROLATE	15.6MCG/INH	POWDER / INHALATION		RLD	2015-10-29

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
N207923-001	8479730	2028-10-11		Drug product	2015-12-04
N207923-001	8182838	2028-10-20		Drug product	2015-12-04

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 · 43 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	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207923-001	SEEBRI NEOHALER	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD, RS	2015-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 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	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207923-001	8479730	2028-10-11		Drug product	2015-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207923-001	8182838	2028-10-20		Drug product	2015-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207923-001	7229607	2021-04-09	U-1773		2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207923-001	8029768	2021-04-09	U-1773		2015-12-04	`74a2ff9319b5…`

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 6 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Quinn Pharmaceuticals	e1ded8e0-c05b-4bf4-a129-57d1726af6ed	2022-12-20	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	26cdd84d-ffa0-4e52-b359-4acef4bd8093	2022-11-10	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Camber Pharmaceuticals, Inc.	4741be85-3abb-4545-aba9-281f64d210ec	2022-07-13	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Novadoz Pharmaceuticals LLC	98820c01-1853-45d8-9da5-875fcdf5f9ab	2022-06-14	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Xiromed LLC	29618edf-39b0-022a-9875-9d865450d318	2022-04-12	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Xiromed, LLC	f777c813-3232-d744-8bcf-58e86fb929bd	2022-04-12	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	516cc4f8-3583-4405-ab66-29d4fcc56d05	2022-03-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	d5a18d74-0d40-46e2-aa0a-41d18609a536	2022-03-04	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	BE Pharmaceuticals Inc.	d9df3900-a8c2-438b-8971-ba11ff91f90b	2022-02-24	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	AuroMedics Pharma LLC	eaebb511-1738-4d11-b9bb-317a8d41316a	2021-12-22	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Nivagen Pharmaceuticals, Inc.	7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177	2021-10-29	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Alembic Labs LLC	db178372-51d2-4194-bbe2-da9acb1cfd53	2020-12-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	9f7f1ebf-58e8-4ae7-8157-1595df8ad6f4	2020-02-26	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Dr. Reddy's Laboratories Limited	725529e8-9c4b-4108-690a-e4f391439736	2016-11-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0662	SEEBRI NEOHALER	glycopyrrolate	Novartis Pharmaceuticals Corporation	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current
63402-815	SEEBRI NEOHALER	GLYCOPYRROLATE	Sunovion Pharmacueticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68251	SUPPL	2021-08-02
68244	SUPPL	2021-08-02
46945	SUPPL	2017-01-24
46942	SUPPL	2017-01-24
46078	ORIG	2016-12-06
46028	ORIG	2016-12-06
32864	ORIG	2015-11-03
19972	ORIG	2015-11-03