Home Applications 209543 Application 209543
Type ANDA
Sponsor ALEMBIC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE TABLET;ORAL EQ 100MG BASE No No 002 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE TABLET;ORAL EQ 500MG BASE 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 A209543-001 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 A209543-002 BOSUTINIB MONOHYDRATE BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A209543-001 PC 2026-12-08 A209543-002 PC 2026-12-08
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 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209543-001 BOSUTINIB MONOHYDRATE EQ 100MG BASE TABLET / ORAL AB 2025-05-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209543-002 BOSUTINIB MONOHYDRATE EQ 500MG BASE TABLET / ORAL AB 2025-05-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A209543-001 PC 2026-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209543-002 PC 2026-12-08 caaa826d4ba7…
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 · 2 matching rows.