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 1.

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 · 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207923-001	SEEBRI	15.6MCG/INH	POWDER / INHALATION	RLD	2015-10-29	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 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	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…`
2019-12-13 00:20 UTC	2019-12	N207923-001	7736670	2021-06-27		Drug product	2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207923-001	8048451	2021-06-27		Drug product	2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207923-001	8303991	2021-06-27		Drug product	2015-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207923-001	8435567	2021-06-27		Drug product	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 1 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Piramal Critical Care Inc	83d70378-011b-4ce3-e053-2991aa0a22be	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Cardinal Health 107, LLC	65688bed-0d70-4b51-8301-1948b1deade1	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	REMEDYREPACK INC.	220cd5f5-3d71-4fdb-9943-7468799c179f	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Golden State Medical Supply, Inc.	ec15e70c-8473-469a-9f07-ea668783fa07	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Meitheal Pharmaceuticals Inc.	02541cfd-b209-49b9-a73f-13ef18dce06d	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	ff65c5d3-7ba9-4315-a884-199151eb45a5	2026-05-14	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	098c7654-a352-47ee-bf23-6a81f8601266	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Atlantic Biologicals Corp.	50b493d7-8e3b-e459-e063-6394a90addbc	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Gland Pharma Limited	d670bd26-8a44-44be-90e1-107d4c380233	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	741355f5-b695-41bb-a065-4abc687312b2	2026-04-28	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Sagent Pharmaceuticals	55930f87-8964-43b1-b790-c1e6dd2602d2	2026-04-20	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	21c7d201-c0b8-4f16-be4a-681d0b22791e	2026-04-03	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Sandoz Inc	cb1ae370-ec4f-4114-9860-8f736f72b545	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	a338ef22-c243-4075-b02d-bcd5b590104a	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	REMEDYREPACK INC.	fafea739-87d0-4421-833f-eb066791504c	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Lifestar Pharma LLC	0f4a4b94-71e0-49ed-8f1e-c760e4dd3137	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Major Pharmaceuticals	6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Bionpharma Inc.	512d3f1e-c35c-87c2-e063-6394a90a8de0	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	NCS HealthCare of KY, LLC dba Vangard Labs	5ed930b7-a36e-4bf8-b1d1-dad238d3dd18	2026-02-25	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	10ea264f-e157-4e13-9d79-b4228daf359d	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE

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