Home Applications 210868 Application 210868
Type NDA
Sponsor PFIZER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORBRENA LORLATINIB TABLET;ORAL 25MG Yes No 002 LORBRENA LORLATINIB TABLET;ORAL 100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N210868-001 LORBRENA LORLATINIB 25MG TABLET / ORAL RLD 2018-11-02 N210868-002 LORBRENA LORLATINIB 100MG TABLET / ORAL RLD, RS 2018-11-02
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210868-001 ODE-349 2028-03-03 N210868-002 ODE-349 2028-03-03
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.
Product history page 1 of 3 · 82 observed 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 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210868-001 LORBRENA 25MG TABLET / ORAL RLD 2018-11-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210868-002 LORBRENA 100MG TABLET / ORAL RLD, RS 2018-11-02 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 9 · 352 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 11020376 2036-07-27 Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-001 11299500 2038-10-04 Drug substance 2022-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 8680111 2033-03-05 Drug substance, Drug product 2018-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 10420749 2036-07-27 U-2633 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 10420749 2036-07-27 U-3096 Drug substance, Drug product 2019-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 11020376 2036-07-27 Drug product 2021-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210868-002 11299500 2038-10-04 Drug substance 2022-05-11 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 11 · 404 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0227 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0231 Lorbrena lorlatinib Pfizer Laboratories Div Pfizer Inc NDA Current