Application 021527

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATROVENT HFA	IPRATROPIUM BROMIDE	AEROSOL, METERED;INHALATION	0.021MG/INH	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021527-001	ATROVENT HFA	IPRATROPIUM BROMIDE	0.021MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2004-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021527-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021527-001	8474447	2030-01-17		Drug product, Delist requested	2015-05-28

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 · 42 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
2026-08-18 06:07:40	2026-07	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION	AB	RLD, RS	2004-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021527-001	ATROVENT HFA	0.021MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2004-11-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021527-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021527-001	AB	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	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021527-001	8474447	2030-01-17	Drug product, Delist requested	2015-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021527-001	8474447	2030-01-17	Drug product, Delist requested	2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021527-001	8474447	2030-01-17	Drug product, Delist requested	2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021527-001	8474447	2030-01-17	Drug product, Delist requested	2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021527-001	6739333	2020-05-26	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021527-001	6983743	2020-05-26	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021527-001	6739333	2020-05-26	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021527-001	6983743	2020-05-26	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021527-001	6739333	2020-05-26	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021527-001	6983743	2020-05-26	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021527-001	6739333	2020-05-26	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021527-001	6983743	2020-05-26	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021527-001	6739333	2020-05-26	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021527-001	6983743	2020-05-26	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021527-001	6739333	2020-05-26	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021527-001	6983743	2020-05-26	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021527-001	8474447	2030-01-17	Drug product	2015-05-28	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atrovent HFA	IPRATROPIUM BROMIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	170e98ef-5560-4068-be7d-e649068eb884	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021527 application number: NDA021527 ndc (product): 0597-0087

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
0597-0087	Atrovent	ipratropium bromide	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0087	Atrovent	ipratropium bromide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0087	Atrovent	ipratropium bromide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0087	Atrovent	ipratropium bromide	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0087	Atrovent	ipratropium bromide	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
50090-0961	Atrovent	ipratropium bromide	A-S Medication Solutions	NDA	Current
53002-8410	Atrovent	ipratropium bromide	RPK Pharmaceuticals, Inc.	NDA	Current
53002-8410	Atrovent	ipratropium bromide	RPK Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80800	SUPPL	2025-01-02
80799	SUPPL	2025-01-02
68306	SUPPL	2021-08-06
61568	SUPPL	2020-01-14
61563	SUPPL	2020-01-14
15693	SUPPL	2012-08-31
5647	SUPPL	2012-08-31
37158	SUPPL	2011-10-12
28031	SUPPL	2011-10-12
5646	SUPPL	2010-12-28
15692	SUPPL	2010-12-26
28030	SUPPL	2008-10-22
21718	ORIG	2007-01-23
15691	SUPPL	2006-09-15
5645	SUPPL	2006-09-15
28029	SUPPL	2006-04-05
15690	ORIG	2004-12-03
5644	ORIG	2004-12-02