Home Applications 218550 Application 218550
Type NDA
Sponsor GENENTECH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROZLYTREK ENTRECTINIB PELLETS;ORAL 50MG/PACKET Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N218550-001 ROZLYTREK ENTRECTINIB 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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.
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 2026-02-19 14:30 UTC 2026-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 58 observed states.
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 77880 ORIG 2024-03-20 77497 ORIG 2024-02-14 75886 SUPPL 2023-10-20