Home Applications 202668 Application 202668
Type ANDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUOROURACIL FLUOROURACIL INJECTABLE;INJECTION 500MG/10ML (50MG/ML) No No 002 FLUOROURACIL FLUOROURACIL INJECTABLE;INJECTION 1GM/20ML (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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202668-001 FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 A202668-002 FLUOROURACIL FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 1 of 3 · 84 observed 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 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION AP 2012-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202668-001 FLUOROURACIL 500MG/10ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202668-002 FLUOROURACIL 1GM/20ML (50MG/ML) INJECTABLE / INJECTION 2012-07-17 bb7c543d1eb4…
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.
Documents# Document, Submission type, Date table Document Submission type Date 85246 SUPPL 2026-03-03 85229 SUPPL 2026-03-03 77997 SUPPL 2024-03-27 77970 SUPPL 2024-03-26