FDA.reportPublic FDA data

Application 076155

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESPRAY, METERED;NASAL0.042MG/SPRAYNoNo

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
A076155-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076155-001AB

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 22:54:322026-06A076155-001IPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076155-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLCe592b6b5-038a-dbe8-457e-76e88a0f194a2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
ndc (product): 16714-527
Ipratropium BromideIPRATROPIUM BROMIDEApotex Corp.ec4c8c83-0335-544c-271e-4f27c06105ac2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
ndc (product): 60505-0827
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions411ccc2c-ec30-450d-8704-b63095fd343b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
ndc (product): 50090-5968

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-527Ipratropium Bromideipratropium bromideNORTHSTAR RX LLCANDACurrent
50090-5968Ipratropium Bromideipratropium bromideA-S Medication SolutionsANDACurrent
60505-0827Ipratropium Bromideipratropium bromideApotex Corp.ANDACurrent
60505-0827Ipratropium Bromideipratropium bromideApotex Corp.ANDACurrent