Application 021912

Type: NDA
Sponsor: SUNOVION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BROVANA	ARFORMOTEROL TARTRATE	SOLUTION;INHALATION	EQ 0.015MG BASE/2ML	Yes	Yes

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
N021912-001	BROVANA	ARFORMOTEROL TARTRATE	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD	2006-10-06

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD	2006-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD	2006-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION		RLD, RS	2006-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021912-001	BROVANA	EQ 0.015MG BASE/2ML	SOLUTION / INHALATION	AN	RLD, RS	2006-10-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N021912-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021912-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021912-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021912-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021912-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021912-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021912-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021912-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021912-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021912-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021912-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021912-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021912-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021912-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021912-001	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021912-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021912-001	AN	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021912-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021912-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021912-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021912-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021912-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021912-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021912-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021912-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021912-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021912-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021912-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021912-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021912-001	AN	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021912-001	6667344	2021-06-22		Drug product	2012-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	6814953	2021-06-22	U-793		2012-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7348362	2021-06-22	U-793	Drug product	2013-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7462645	2021-06-22	U-793		2013-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7465756	2021-06-22		Drug product	2013-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7473710	2021-06-22	U-793		2013-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7541385	2021-06-22	U-793		2013-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	6472563	2021-11-09		Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	6720453	2021-11-09		Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	7145036	2021-11-09		Drug substance		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021912-001	8110706	2021-11-09		Drug product	2012-02-09	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021912-001	6667344	2021-06-22		Drug product	2012-06-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	6814953	2021-06-22	U-793		2012-06-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7348362	2021-06-22	U-793	Drug product	2013-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7462645	2021-06-22	U-793		2013-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7465756	2021-06-22		Drug product	2013-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7473710	2021-06-22	U-793		2013-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7541385	2021-06-22	U-793		2013-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	6472563	2021-11-09		Drug substance		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	6720453	2021-11-09		Drug substance		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	7145036	2021-11-09		Drug substance		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021912-001	8110706	2021-11-09		Drug product	2012-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	6667344	2021-06-22		Drug product	2012-06-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	6814953	2021-06-22	U-793		2012-06-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7348362	2021-06-22	U-793	Drug product	2013-07-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7462645	2021-06-22	U-793		2013-07-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7465756	2021-06-22		Drug product	2013-07-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7473710	2021-06-22	U-793		2013-07-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7541385	2021-06-22	U-793		2013-07-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	6472563	2021-11-09		Drug substance		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	6720453	2021-11-09		Drug substance		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	7145036	2021-11-09		Drug substance		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021912-001	8110706	2021-11-09		Drug product	2012-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021912-001	6667344	2021-06-22		Drug product	2012-06-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	6814953	2021-06-22	U-793		2012-06-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	7348362	2021-06-22	U-793	Drug product	2013-07-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	7462645	2021-06-22	U-793		2013-07-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	7465756	2021-06-22		Drug product	2013-07-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	7473710	2021-06-22	U-793		2013-07-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021912-001	7541385	2021-06-22	U-793		2013-07-11	`5aa47cf7b7d7…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	Sun Pharmaceutical Industries, Inc.	f1005878-0c48-4b9a-843e-b6cf6b8bb251	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
arformoterol tartrate	ARFORMOTEROL TARTRATE	Lifestar Pharma LLC	e9eb1ac7-57aa-4ef8-aac3-14def5b883d0	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol tartrate	ARFORMOTEROL TARTRATE	Alembic Pharmaceuticals Inc.	f2feda53-54b9-4e40-8a01-9e7b45cb3d8c	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
arformoterol tartrate	ARFORMOTEROL TARTRATE	NorthStar RxLLC	6a498c49-042f-481f-bc5c-a2fc00dc5668	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
arformoterol tartrate	ARFORMOTEROL TARTRATE	Cipla USA Inc.	70071afd-5323-4019-aca5-5534278829dc	2025-08-21	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	Ingenus Pharmaceuticals, LLC	9572582e-8cc2-4d3d-b9dc-c2b8159d71d8	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	Micro Labs Limited	6838a595-19cc-454a-96b9-ff83b93881ae	2025-04-18	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol tartrate	ARFORMOTEROL TARTRATE	Lupin Pharmaceuticals, Inc.	cf1f2d1b-0455-4113-9647-507faf49fdd0	2025-03-11	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol Tartrate Inhalation Solution	ARFORMOTEROL TARTRATE	Aucta Pharmaceuticals, Inc.	8c0d81db-fbf5-405f-9311-d3d78992d9a3	2025-02-11	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol tartrate	ARFORMOTEROL TARTRATE	Fosun Pharma USA Inc.	26e06ee1-f9d6-5167-e063-6394a90a6d32	2024-10-02	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
arformoterol tartrate	ARFORMOTEROL TARTRATE	Dr. Reddy's Laboratories, Inc.	d8843369-b0d5-6f0d-1fcd-0c49002df755	2024-09-02	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE
Arformoterol Tartrate	ARFORMOTEROL TARTRATE	American Health Packaging	bb1a6643-f280-4f02-a824-0428a2b82d3c	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: ARFORMOTEROL TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63402-911	Brovana	arformoterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-911	Brovana	arformoterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-911	Brovana	arformoterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-911	Brovana	arformoterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-911	Brovana	arformoterol tartrate	Sunovion Pharmaceuticals Inc.	NDA	Current
70748-257	Arformoterol Tartrate	Arformoterol Tartrate	Lupin Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58962	SUPPL	2019-06-04
58896	SUPPL	2019-05-31
56236	SUPPL	2018-11-01
37872	SUPPL	2014-03-04
6444	SUPPL	2014-03-04
28840	SUPPL	2012-08-13
6443	SUPPL	2012-08-13
6442	SUPPL	2011-09-07
37871	SUPPL	2011-07-18
28838	SUPPL	2011-07-18
16567	SUPPL	2011-02-24
28839	SUPPL	2011-02-18
6441	SUPPL	2011-02-07
6440	SUPPL	2010-06-03
16566	SUPPL	2010-06-02
24227	ORIG	2009-04-14
21869	ORIG	2009-04-14
28837	SUPPL	2008-01-09
37870	SUPPL	2008-01-08
44160	ORIG	2007-02-20
28836	ORIG	2006-10-13
16565	ORIG	2006-10-11