FDA.reportPublic FDA data

Application 076291

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESOLUTION;INHALATION0.02%NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076291-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC6b730dd7-4d93-403a-bfd2-fa0efa298b752026-07-24Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERising Pharma Holdings, Inc.3249aea8-a395-f09f-e063-6294a90a2d8b2026-07-16Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESportpharm LLC7e8fdd92-1e55-47e2-aa85-e48cfebbb8d72026-07-14Warnings, Adverse reactionsName fallback
brand name: IPRATROPIUM BROMIDE
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDECardinal Health 107, LLC51350fab-a919-4d97-9d0c-d9dc7286244c2026-06-02Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLCe592b6b5-038a-dbe8-457e-76e88a0f194a2026-02-27Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLC6493c00f-2306-2cb6-9624-4ea678f665762026-02-27Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDELupin Pharmaceuticals, Inc.13a45df5-a8e3-41d6-91f4-773255b5a04b2026-01-08Warnings, Adverse reactionsName fallback
brand name: IPRATROPIUM BROMIDE
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDELupin Pharmaceuticals, Inc.ee0ac556-8a23-4d5c-a5da-881c1fc6a3392026-01-08Warnings, Adverse reactionsName fallback
brand name: IPRATROPIUM BROMIDE
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltdbb5f7711-595f-4f7c-9e89-66d029ccbccb2025-12-12Warnings, Adverse reactionsName fallback
brand name: IPRATROPIUM BROMIDE
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEChartwell RX, LLC1e3d4faa-cf6e-460b-b1e0-fcc8094505fa2025-12-02Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Atrovent HFAIPRATROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.170e98ef-5560-4068-be7d-e649068eb8842025-11-05Warnings, Adverse reactionsName fallback
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEApotex Corp.ec4c8c83-0335-544c-271e-4f27c06105ac2025-09-18Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEApotex Corp.ac641027-929e-694d-80cd-bf770dc51aa62025-09-18Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEOceanside Pharmaceuticalsb1a5e41a-9100-41d5-a7d0-2e763ad5efb62025-08-06Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENephron Pharmaceuticals Corporationdb8095db-d1fd-4099-9fb1-d1ad4e2849762025-04-08Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltd4874e61a-5abe-4d1d-a30f-65b3e092db262025-01-29Warnings, Adverse reactionsName fallback
brand name: IPRATROPIUM BROMIDE
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions411ccc2c-ec30-450d-8704-b63095fd343b2025-01-22Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE
Ipratropium BromideIPRATROPIUM BROMIDENuCare Pharmaceuticals, Inc.2b9b619a-5e2a-73ef-e063-6394a90a97fe2025-01-13Warnings, Adverse reactionsName fallback
brand name: Ipratropium Bromide
generic name: IPRATROPIUM BROMIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-911Ipratropium BromideIpratropium BromideRebel Distributors CorpANDACurrent