Home Applications 218922 Application 218922
Type NDA
Sponsor CIPLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 50MG BASE Yes No 002 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 150MG BASE Yes No 003 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 200MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218922-001 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 N218922-002 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 N218922-003 NILOTINIB D-TARTRATE NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD 2025-02-19
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 2026-10-15 13:18:30 2026-09 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD 2025-02-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD 2025-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218922-001 NILOTINIB D-TARTRATE EQ 50MG BASE CAPSULE / ORAL RLD 2025-02-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218922-002 NILOTINIB D-TARTRATE EQ 150MG BASE CAPSULE / ORAL RLD 2025-02-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218922-003 NILOTINIB D-TARTRATE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2025-02-19 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 85098 ORIG 2026-02-20 82813 SUPPL 2025-07-11 82812 SUPPL 2025-07-11 82787 SUPPL 2025-07-11 81305 ORIG 2025-02-21 81291 ORIG 2025-02-20