Application 022007

Type: NDA
Sponsor: MYLAN SPECLT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERFOROMIST	FORMOTEROL FUMARATE	SOLUTION;INHALATION	0.02MG/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
N022007-001	PERFOROMIST	FORMOTEROL FUMARATE	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022007-001	AN

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	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION		RLD, RS	2007-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022007-001	PERFOROMIST	0.02MG/2ML	SOLUTION / INHALATION	AN	RLD, RS	2007-05-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022007-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022007-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022007-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022007-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022007-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022007-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022007-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022007-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022007-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022007-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022007-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022007-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022007-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022007-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022007-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022007-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022007-001	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022007-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022007-001	AN	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022007-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022007-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022007-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022007-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022007-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022007-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022007-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022007-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022007-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022007-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022007-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022007-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022007-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022007-001	AN	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 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	N022007-001	6667344	2021-06-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022007-001	6814953	2021-06-22	U-813	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022007-001	7348362	2021-06-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022007-001	7462645	2021-06-22	U-813	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022007-001	6667344	2021-06-22		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022007-001	6814953	2021-06-22	U-813	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022007-001	7348362	2021-06-22		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022007-001	7462645	2021-06-22	U-813	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	6667344	2021-06-22		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	6814953	2021-06-22	U-813	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	7348362	2021-06-22		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	7462645	2021-06-22	U-813	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022007-001	6667344	2021-06-22		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022007-001	6814953	2021-06-22	U-813	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022007-001	7348362	2021-06-22		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022007-001	7462645	2021-06-22	U-813	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022007-001	6667344	2021-06-22		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022007-001	6814953	2021-06-22	U-813	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022007-001	7348362	2021-06-22		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022007-001	7462645	2021-06-22	U-813	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022007-001	6667344	2021-06-22		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022007-001	6814953	2021-06-22	U-813	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022007-001	7348362	2021-06-22		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022007-001	7462645	2021-06-22	U-813	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022007-001	8623922	2021-06-22		Drug product	2014-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022007-001	9730890	2021-06-22		Drug product	2018-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022007-001	6667344	2021-06-22		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022007-001	6814953	2021-06-22	U-813	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022007-001	7348362	2021-06-22		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022007-001	7462645	2021-06-22	U-813	Drug product		`3f01610625f2…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FORMOTEROL FUMARATE	FORMOTEROL FUMARATE DIHYDRATE	Mylan Pharmaceuticals Inc.	6c1a6c53-af85-4220-9ce3-2373e0928f7f	2020-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022007 application number: NDA022007 ndc (product): 0378-1631
Perforomist	FORMOTEROL FUMARATE DIHYDRATE	Viatris Specialty LLC	fb2fe258-fe2e-47f6-8adf-ca75bf6f90af	2019-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022007 application number: NDA022007 ndc (product): 49502-605

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1631	FORMOTEROL FUMARATE	formoterol fumarate dihydrate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-1631	FORMOTEROL FUMARATE	formoterol fumarate dihydrate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-1631	FORMOTEROL FUMARATE	formoterol fumarate dihydrate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-1631	FORMOTEROL FUMARATE	formoterol fumarate dihydrate	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
49502-605	Perforomist	formoterol fumarate dihydrate	Mylan Specialty L.P.	NDA	Current
49502-605	Perforomist	formoterol fumarate dihydrate	Mylan Specialty L.P.	NDA	Current
49502-605	Perforomist	formoterol fumarate dihydrate	Mylan Specialty L.P.	NDA	Current
49502-605	Perforomist	formoterol fumarate dihydrate	Mylan Specialty L.P.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58958	SUPPL	2019-06-04
58897	SUPPL	2019-05-31
56133	SUPPL	2018-10-29
56132	SUPPL	2018-10-29
56057	SUPPL	2018-10-23
50571	SUPPL	2017-12-01
50550	SUPPL	2017-12-01
29058	SUPPL	2012-10-02
6670	SUPPL	2012-10-02
38072	SUPPL	2012-01-23
29057	SUPPL	2012-01-17
29056	SUPPL	2011-02-07
23338	ORIG	2010-06-04
29055	SUPPL	2010-06-03
38071	SUPPL	2010-06-02
21902	ORIG	2009-03-19
44167	ORIG	2008-04-01
16752	ORIG	2008-03-28
29054	ORIG	2007-05-31
6669	ORIG	2007-05-01