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 44 .
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 2026-10-15 13:18:30 2026-09 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218550-001 ROZLYTREK 50MG/PACKET PELLETS / ORAL RLD, RS 2023-10-20 caaa826d4ba7…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 · 70 observed states.
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 77880 ORIG 2024-03-20 77497 ORIG 2024-02-14 75886 SUPPL 2023-10-20