FDA.reportPublic FDA data

Application 207903

Type
ANDA
Sponsor
SUN PHARM

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
A207903-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2017-01-03

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 22:54:322026-06A207903-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2017-01-03a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDESun Pharmaceutical Industries, Inc.231ae8f2-1ec9-4e0f-90a8-11d7b62225762022-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207903
application number: ANDA207903
ndc (product): 47335-706

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-706Ipratropium BromideIpratropium BromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-706Ipratropium BromideIpratropium BromideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-706Ipratropium BromideIpratropium BromideSun Pharmaceutical Industries, Inc.ANDACurrent