Application 017391

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMURANAZATHIOPRINE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N017391-001IMURANAZATHIOPRINE SODIUMEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

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 22:54:322026-06N017391-001IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMURANAZATHIOPRINESebela Pharmaceuticals Inc.606101a0-6244-7eff-e053-2a91aa0acadd2025-11-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IMURAN
Azathioprine SodiumAZATHIOPRINE SODIUMHikma Pharmaceuticals USA Inc.9ffe79a1-ac91-4a7b-a9e3-7c84bfa9ddf02025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AZATHIOPRINE SODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79049SUPPL 2024-07-11
79033SUPPL 2024-07-10
57003SUPPL2018-12-21
56944SUPPL2018-12-21
13128SUPPL2014-02-11
33259SUPPL2014-02-07
13127SUPPL2011-05-26
33258SUPPL2011-05-25
575SUPPL2008-07-14
10981SUPPL2008-07-10
10980SUPPL2005-07-29
574SUPPL2005-07-29
573SUPPL2003-07-24