FDA.reportPublic FDA data

Application 211864

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDEINJECTABLE;INJECTION0.2MG/MLNoNo

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
A211864-001ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTION2021-02-09

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 22:54:322026-06A211864-001ISOPROTERENOL HYDROCHLORIDE0.2MG/MLINJECTABLE / INJECTION2021-02-09a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isoproterenol HydrochlorideISOPROTERENOL HYDROCHLORIDEEugia US LLC3e4050e8-7d94-4ed7-951d-1ff818ddadf12025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211864
application number: ANDA211864
ndc (product): 55150-316
ndc (product): 55150-317

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
55150-316Isoproterenol HydrochlorideIsoproterenol HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-316Isoproterenol HydrochlorideIsoproterenol HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-317Isoproterenol HydrochlorideIsoproterenol HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-317Isoproterenol HydrochlorideIsoproterenol HydrochlorideAuroMedics Pharma LLCANDACurrent