Application 021747

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMBIVENT RESPIMAT	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	SPRAY, METERED;INHALATION	EQ 0.1MG BASE/INH;0.02MG/INH	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
N021747-001	COMBIVENT RESPIMAT	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	EQ 0.1MG BASE/INH;0.02MG/INH	SPRAY, METERED / INHALATION		RLD, RS	2011-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02
N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04
N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02
N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04

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	N021747-001	COMBIVENT RESPIMAT	EQ 0.1MG BASE/INH;0.02MG/INH	SPRAY, METERED / INHALATION	RLD, RS	2011-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021747-001	COMBIVENT RESPIMAT	EQ 0.1MG BASE/INH;0.02MG/INH	SPRAY, METERED / INHALATION	RLD, RS	2011-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021747-001	COMBIVENT RESPIMAT	EQ 0.1MG BASE/INH;0.02MG/INH	SPRAY, METERED / INHALATION	RLD, RS	2011-10-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021747-001	COMBIVENT RESPIMAT	EQ 0.1MG BASE/INH;0.02MG/INH	SPRAY, METERED / INHALATION	RLD, RS	2011-10-07	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 267 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021747-001	7396341	2026-10-10	Drug product, Delist requested	2011-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021747-001	9027967	2027-03-31	Drug product, Delist requested	2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021747-001	7837235	2028-03-13	Drug product, Delist requested	2011-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021747-001	8733341	2030-10-16	Drug product, Delist requested	2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021747-001	7896264	2025-05-26	Drug product	2011-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021747-001	7396341	2026-10-10	Drug product	2011-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021747-001	9027967	2027-03-31	Drug product	2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021747-001	7837235	2028-03-13	Drug product	2011-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021747-001	8733341	2030-10-16	Drug product	2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021747-001	7896264	2025-05-26	Drug product	2011-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021747-001	7396341	2026-10-10	Drug product	2011-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021747-001	9027967	2027-03-31	Drug product	2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021747-001	7837235	2028-03-13	Drug product	2011-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021747-001	8733341	2030-10-16	Drug product	2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	7284474	2024-08-26	Drug product	2011-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	7896264	2025-05-26	Drug product	2011-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	7396341	2026-10-10	Drug product	2011-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	9027967	2027-03-31	Drug product	2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	7837235	2028-03-13	Drug product	2011-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021747-001	8733341	2030-10-16	Drug product	2015-09-04	`03ed91905a0d…`

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
Combivent Respimat	IPRATROPIUM BROMIDE AND ALBUTEROL	Boehringer Ingelheim Pharmaceuticals, Inc.	9832312e-0310-4ab6-8501-afa976fc7eb2	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021747 application number: NDA021747 ndc (product): 0597-0024

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0024	Combivent Respimat	ipratropium bromide and albuterol	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64747	SUPPL	2020-09-29
64728	SUPPL	2020-09-29
16301	SUPPL	2016-06-13
6109	SUPPL	2016-06-10
16300	SUPPL	2016-02-25
6108	SUPPL	2016-02-01
28512	SUPPL	2014-10-22
16299	SUPPL	2014-10-21
37574	SUPPL	2012-08-31
28511	SUPPL	2012-08-31
42296	ORIG	2012-08-16
24215	ORIG	2012-08-16
28510	ORIG	2011-10-12
16298	ORIG	2011-10-12