Home Applications 075552 Application 075552
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 0.021MG/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 A075552-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075552-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL 2003-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075552-001 IPRATROPIUM BROMIDE 0.021MG/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 2 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 A-S Medication Solutions 7159cf05-da58-4eb9-9e6d-a7f24eec5f46 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Bryant Ranch Prepack 43ef9085-64e4-429a-a614-926d9a3652b7 2024-11-08 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE American Health Packaging 8927f392-4c88-4ac1-a934-c444ecf6b2c8 2024-06-03 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Amneal Pharmaceuticals NY LLC 61820346-29d9-4864-b8f4-4a198b8ac594 2023-12-30 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Amneal Pharmaceuticals NY LLC 3bda47b0-0326-49de-83f5-03b9ec6461f1 2023-12-30 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Bryant Ranch Prepack fcf20db7-091d-40de-8755-03773fc47edd 2023-12-07 Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium bromide IPRATROPIUM BROMIDE Aurobindo Pharma Limited ff2b6bda-4acd-41fd-8970-458c5265df21 2023-10-30 Warnings, Adverse reactions Name fallback brand name: Ipratropium bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE A-S Medication Solutions 9f7b2f09-e831-4e15-b226-5cef3b613bd1 2023-02-16 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Hikma Pharmaceuticals USA Inc. 71bdbbb9-8696-416d-bed4-7259929c0161 2022-07-01 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Hikma Pharmaceuticals USA Inc. 05c56190-e346-4674-a4f8-049ce632ce2d 2022-07-01 Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Sun Pharmaceutical Industries, Inc. 231ae8f2-1ec9-4e0f-90a8-11d7b6222576 2022-04-13 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Bausch & Lomb Incorporated 3fd850a2-af0f-4291-af5d-52c8d6094e64 2019-05-01 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE Ipratropium bromide IPRATROPIUM BROMIDE Bausch & Lomb Incorporated 1e92b86d-66e1-45e4-9e23-f9310c95bf82 2019-05-01 Warnings, Adverse reactions Name fallback brand name: Ipratropium bromide generic name: IPRATROPIUM BROMIDE Ipratropium Bromide IPRATROPIUM BROMIDE Mylan Pharmaceuticals Inc. f625d3e3-c175-4d9a-99ea-dab410b262f1 2013-06-24 Warnings, Adverse reactions Name fallback brand name: Ipratropium Bromide generic name: IPRATROPIUM BROMIDE
Documents# Document, Submission type, Date table Document Submission type Date 43003 ORIG 2007-09-26