Application 075553

Type: ANDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	SPRAY, METERED;NASAL	0.042MG/SPRAY	No	No

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
A075553-001	IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL			2003-03-31

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075553-001	IPRATROPIUM BROMIDE	0.042MG/SPRAY	SPRAY, METERED / NASAL	2003-03-31	`cb3db0bc1861…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ipratropium Bromide	IPRATROPIUM BROMIDE	Cardinal Health 107, LLC	6b730dd7-4d93-403a-bfd2-fa0efa298b75	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Rising Pharma Holdings, Inc.	3249aea8-a395-f09f-e063-6294a90a2d8b	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	Sportpharm LLC	7e8fdd92-1e55-47e2-aa85-e48cfebbb8d7	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: IPRATROPIUM BROMIDE generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Cardinal Health 107, LLC	51350fab-a919-4d97-9d0c-d9dc7286244c	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Redpharm Drug	52c63e41-dbbc-d9d7-e063-6294a90a30c9	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	NORTHSTAR RX LLC	e592b6b5-038a-dbe8-457e-76e88a0f194a	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	NORTHSTAR RX LLC	6493c00f-2306-2cb6-9624-4ea678f66576	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	Lupin Pharmaceuticals, Inc.	13a45df5-a8e3-41d6-91f4-773255b5a04b	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: IPRATROPIUM BROMIDE generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	Lupin Pharmaceuticals, Inc.	ee0ac556-8a23-4d5c-a5da-881c1fc6a339	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: IPRATROPIUM BROMIDE generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	Advagen Pharma Ltd	bb5f7711-595f-4f7c-9e89-66d029ccbccb	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: IPRATROPIUM BROMIDE generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Ritedose Pharmaceuticals, LLC	22479633-624a-4251-ad3c-1dcba5d503fb	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Chartwell RX, LLC	1e3d4faa-cf6e-460b-b1e0-fcc8094505fa	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Atrovent HFA	IPRATROPIUM BROMIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	170e98ef-5560-4068-be7d-e649068eb884	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Apotex Corp.	ec4c8c83-0335-544c-271e-4f27c06105ac	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Apotex Corp.	ac641027-929e-694d-80cd-bf770dc51aa6	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Oceanside Pharmaceuticals	b1a5e41a-9100-41d5-a7d0-2e763ad5efb6	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	Nephron Pharmaceuticals Corporation	db8095db-d1fd-4099-9fb1-d1ad4e284976	2025-04-08	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE	IPRATROPIUM BROMIDE	Advagen Pharma Ltd	4874e61a-5abe-4d1d-a30f-65b3e092db26	2025-01-29	Warnings, Adverse reactions	Name fallback brand name: IPRATROPIUM BROMIDE generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	A-S Medication Solutions	411ccc2c-ec30-450d-8704-b63095fd343b	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Ipratropium Bromide	IPRATROPIUM BROMIDE	NuCare Pharmaceuticals, Inc.	2b9b619a-5e2a-73ef-e063-6394a90a97fe	2025-01-13	Warnings, Adverse reactions	Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22484	ORIG	2007-09-26