Home Applications 214809 Application 214809
Type ANDA
Sponsor SHORLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NELARABINE NELARABINE INJECTABLE;INTRAVENOUS 250MG/50ML (5MG/ML) No No 002 NELARABINE NELARABINE INJECTABLE;INTRAVENOUS 375MG/75ML (5MG/ML) No Yes
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 A214809-001 NELARABINE NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 A214809-002 NELARABINE NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214809-001 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 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214809-002 NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214809-002 NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214809-002 NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214809-002 NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214809-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2023-03-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214809-002 NELARABINE 375MG/75ML (5MG/ML) INJECTABLE / INTRAVENOUS RS 2025-07-16 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 nelarabine NELARABINE Shorla Oncology Inc. fc401b06-4e3b-413e-a854-3e031c433862 2025-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214809 application number: ANDA214809