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 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
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 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	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 482 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	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…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208437-001	7931212	2025-11-25		Drug product	2018-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`6a471c1ec25d…`

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 5 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	54458620-d888-4df6-ae4b-78c3dfed3423	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	88d3e865-8dca-4c89-b6f7-a34c481f75b9	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Bryant Ranch Prepack	4c733750-45fe-4876-8e4f-c61c52470405	2023-06-06	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	86abf577-562c-5eb1-e053-2a91aa0ac10f	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	66726c2b-27e8-5dd1-e053-2991aa0a1ba7	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	69353cc1-f5d4-170b-e053-2a91aa0ad5a5	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	6934f467-949f-97cc-e053-2a91aa0a05fb	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	95fbe384-eaff-1f2e-e053-2a95a90a0313	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f126596-7fbf-7a48-e053-2995a90abac7	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	8f12016d-9033-00b4-e053-2a95a90ad02a	2023-05-15	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9c9666bf-841b-03fa-e053-2a95a90abb48	2023-05-11	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	9e5113b7-1c0c-24bd-e053-2995a90ab94b	2023-05-09	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	bbf0abe2-8deb-19b2-e053-2a95a90a60a3	2023-05-08	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	b622f21f-fa37-1259-e053-2995a90aa796	2023-05-04	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	a2a2a03f-21cc-5fec-e053-2995a90a84cb	2023-05-03	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	LGM PHARMA SOLUTIONS, LLC	392a969d-1e14-4ad8-835c-a47be4983067	2023-04-27	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	e8bb95ed-09f1-fcf1-e053-2a95a90a93e5	2023-04-25	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	ea4c8be4-a1e9-5901-e053-2995a90a5e63	2023-04-24	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	3ac4f32f-f5ca-4a6d-9bc7-2672d478b3d4	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Meitheal Pharmaceuticals Inc.	02f914a8-2356-4525-91ff-cf0c9e41ba23	2023-01-12	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