Application 076156

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	SPRAY, METERED;NASAL	0.021MG/SPRAY	No	No

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
A076156-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB		2003-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076156-001	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL		2003-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL		2003-04-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL		2003-04-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL		2003-04-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076156-001	IPRATROPIUM BROMIDE	0.021MG/SPRAY	SPRAY, METERED / NASAL	AB	2003-04-18	`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	A076156-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076156-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076156-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076156-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076156-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076156-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076156-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076156-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076156-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076156-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076156-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076156-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076156-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076156-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076156-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076156-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076156-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076156-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A076156-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076156-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076156-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076156-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076156-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076156-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076156-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076156-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076156-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076156-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076156-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076156-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076156-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076156-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076156-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076156-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076156-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076156-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076156-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076156-001	AB	1	`a50c72e98297…`

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
Ipratropium Bromide	IPRATROPIUM BROMIDE	NORTHSTAR RX LLC	6493c00f-2306-2cb6-9624-4ea678f66576	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076156 application number: ANDA076156 ndc (product): 16714-526
Ipratropium Bromide	IPRATROPIUM BROMIDE	Apotex Corp.	ac641027-929e-694d-80cd-bf770dc51aa6	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076156 application number: ANDA076156 ndc (product): 60505-0826

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-526	Ipratropium Bromide	Ipratropium Bromide	NORTHSTAR RX LLC	ANDA	Current
60505-0826	Ipratropium Bromide	Ipratropium Bromide	Apotex Corp.	ANDA	Current
60505-0826	Ipratropium Bromide	Ipratropium Bromide	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22540	ORIG	2005-07-22