Home Applications 216494 Application 216494
Type ANDA
Sponsor KINDOS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOROURACIL FLUOROURACIL INJECTABLE;INJECTION 2.5GM/50ML (50MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216494-001 FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216494-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216494-001 FLUOROURACIL 2.5GM/50ML (50MG/ML) INJECTABLE / INJECTION AP 2024-09-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluorouracil FLUOROURACIL Meitheal Pharmaceuticals Inc. a0cd6301-c6e0-4b62-8683-39c99913db24 2026-04-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216494 application number: ANDA216494
Documents# Document, Submission type, Date table Document Submission type Date 85256 SUPPL 2026-03-03 85238 SUPPL 2026-03-03