FDA.reportPublic FDA data

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SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 44.

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SODIUMEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017391-001IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017391-001IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017391-001IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017391-001IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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