Application 208437

Type: NDA
Sponsor: SUNOVION RESP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LONHALA MAGNAIR KIT	GLYCOPYRROLATE	SOLUTION;INHALATION	25MCG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208437-001	LONHALA MAGNAIR KIT	GLYCOPYRROLATE	25MCG/ML	SOLUTION / INHALATION		RLD	2017-12-05

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208437-001	11278683	2026-08-16		Drug product	2022-03-25
N208437-001	9265900	2028-12-07		Drug product	2018-01-02
N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16
N208437-001	9789270	2030-10-30		Drug product	2018-01-02
N208437-001	9168556	2032-09-01		Drug product	2018-01-02
N208437-001	9604018	2033-05-16		Drug product	2018-01-02
N208437-001	10376661	2035-09-14		Drug product	2019-09-05
N208437-001	10688518	2036-11-12		Drug product	2020-06-30
N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 491 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	7931212	2025-11-25		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208437-001	NP	2020-12-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208437-001	NP	2020-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208437-001	NP	2020-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208437-001	NP	2020-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208437-001	NP	2020-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208437-001	NP	2020-12-05	`ea99ee380514…`

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 · 114 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	QUAGEN PHARMACEUTICALS LLC	62e1ba35-bc84-4818-be54-8b534a1bf93c	2026-09-10	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	f7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	4ecb3435-58e5-46cb-b8c2-85b5fd955f83	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	1f266d77-4f9e-44c9-a000-2f8fea3ac80b	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Amneal Pharmaceuticals LLC	bbab4cf1-0441-4fc4-9de9-e4117fa19faa	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
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

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60940-024	Lonhala	Glycopyrrolate	Holopack Verpackungstechnik GmbH	NDA	Current
60940-024	Lonhala	Glycopyrrolate	Holopack Verpackungstechnik GmbH	NDA	Current
60940-024	Lonhala	Glycopyrrolate	Holopack Verpackungstechnik GmbH	NDA	Current
60940-024	Lonhala	Glycopyrrolate	Holopack Verpackungstechnik GmbH	NDA	Current
63402-201	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-201	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-201	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-301	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-301	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-301	LONHALA MAGNAIR	glycopyrrolate	Sunovion Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59179	SUPPL	2019-06-27
59167	SUPPL	2019-06-25
56560	ORIG	2018-11-26
56096	ORIG	2018-10-26
50621	ORIG	2017-12-06