FDA.reportPublic FDA data

Application 071248

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYTARABINECYTARABINEInjectable; Injection100MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CytarabineCYTARABINEHospira, Inc.e3a8c0e9-19ed-49b7-8464-11e8806f47fd2025-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEMeitheal Pharmaceuticals Inc.8105e590-fc7e-45b7-9604-c2d0d1be5eac2024-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
cytarabineCYTARABINESagent Pharmaceuticals90f5c7ab-9f15-487d-ba69-ee4107434bcc2023-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cytarabine
generic name: CYTARABINE
cytarabineCYTARABINESagent Pharmaceuticals9bc7f6c2-4b16-449b-b383-76106540206c2023-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEMeitheal Pharmaceuticals Inc.8b366382-c8d1-4344-86b7-f65e92a8952b2022-08-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEMeitheal Pharmaceuticals Inc.1be2668b-d76f-4c65-aea9-86c5c40889a22022-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEMeitheal Pharmaceuticals Inc.446f6765-5375-6368-4755-4944574f57212022-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEGland Pharma Limitedcb0db038-4a65-42c7-aa79-5c88309061df2020-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE
CytarabineCYTARABINEGland Pharma Limited7ab50348-ca78-46a5-aba6-c35b6b21fbfe2020-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Cytarabine
generic name: CYTARABINE

Reported adverse events (FAERS/openFDA)#

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