FDA.reportPublic FDA data

Application 074784

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATRACURIUM BESYLATEATRACURIUM BESYLATEINJECTABLE;INJECTION10MG/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
A074784-001ATRACURIUM BESYLATEATRACURIUM BESYLATE10MG/MLINJECTABLE / INJECTION1997-06-11

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 22:54:322026-06A074784-001ATRACURIUM BESYLATE10MG/MLINJECTABLE / INJECTION1997-06-11a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atracurium BesylateATRACURIUM BESYLATEMeitheal Pharmaceuticals Inc.efe90ee2-fe9e-421f-9e54-2961085d3b122024-12-04Warnings, Adverse reactionsName fallback
brand name: Atracurium Besylate
generic name: ATRACURIUM BESYLATE
Atracurium BesylateATRACURIUM BESYLATEHospira, Inc.de1c2dcd-295b-47ce-b7a1-a8be59939a542023-11-23Warnings, Adverse reactionsName fallback
brand name: Atracurium Besylate
generic name: ATRACURIUM BESYLATE
Atracurium BesylateATRACURIUM BESYLATEAuroMedics Pharma LLC71d4bc78-57df-474b-8b19-811a959f1fce2022-05-30Warnings, Adverse reactionsName fallback
brand name: Atracurium Besylate
generic name: ATRACURIUM BESYLATE
Atracurium BesylateATRACURIUM BESYLATEAuroMedics Pharma LLCf7b6a720-05a7-4d6a-9200-21bdc90fc1c42022-02-14Warnings, Adverse reactionsName fallback
brand name: Atracurium Besylate
generic name: ATRACURIUM BESYLATE