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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210868-001	LORBRENA	25MG	TABLET / ORAL	RLD	2018-11-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210868-002	LORBRENA	100MG	TABLET / ORAL	RLD, RS	2018-11-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210868-001	LORBRENA	25MG	TABLET / ORAL	RLD	2018-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210868-002	LORBRENA	100MG	TABLET / ORAL	RLD, RS	2018-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210868-001	LORBRENA	25MG	TABLET / ORAL	RLD	2018-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210868-002	LORBRENA	100MG	TABLET / ORAL	RLD, RS	2018-11-02	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 2 of 10 · 382 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	8680111	2033-03-05		Drug substance, Drug product	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	10420749	2036-07-27	U-2633	Drug substance, Drug product	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	10420749	2036-07-27	U-3096	Drug substance, Drug product	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	11020376	2036-07-27		Drug product	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	11299500	2038-10-04		Drug substance	2022-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	8680111	2033-03-05		Drug substance, Drug product	2018-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	10420749	2036-07-27	U-2633	Drug substance, Drug product	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	10420749	2036-07-27	U-3096	Drug substance, Drug product	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	11020376	2036-07-27		Drug product	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	11299500	2038-10-04		Drug substance	2022-05-11	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 410 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N210868-001	ODE-349	2028-03-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210868-002	ODE-349	2028-03-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210868-001	ODE-349	2028-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210868-002	ODE-349	2028-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210868-001	ODE-349	2028-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210868-002	ODE-349	2028-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210868-001	ODE-349	2028-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210868-002	ODE-349	2028-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-001	ODE-217	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-001	ODE-218	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-001	ODE-219	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-001	ODE-349	2028-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-002	ODE-217	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-002	ODE-218	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-002	ODE-219	2025-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210868-002	ODE-349	2028-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210868-001	ODE-217	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-001	ODE-218	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-001	ODE-219	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-001	ODE-349	2028-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-002	ODE-217	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-002	ODE-218	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-002	ODE-219	2025-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210868-002	ODE-349	2028-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-001	ODE-217	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-001	ODE-218	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-001	ODE-219	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-001	ODE-349	2028-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-002	ODE-217	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-002	ODE-218	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-002	ODE-219	2025-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210868-002	ODE-349	2028-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	ODE-217	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	ODE-218	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	ODE-219	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-001	ODE-349	2028-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	ODE-217	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	ODE-218	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	ODE-219	2025-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210868-002	ODE-349	2028-03-03	`b8a1b40f171c…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorbrena	LORLATINIB	Pfizer Laboratories Div Pfizer Inc	2b34d62d-e02a-4af3-bc0d-1571dd4ee76d	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210868 application number: NDA210868 ndc (product): 0069-0231 ndc (product): 0069-0227
Lorbrena	LORLATINIB	U.S. Pharmaceuticals	004f93d7-a1cd-4b67-9207-31cdcb5c5976	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210868 application number: NDA210868

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84946	SUPPL	2026-02-05
84884	SUPPL	2026-01-30
83607	SUPPL	2025-09-30
83606	SUPPL	2025-09-30
66489	SUPPL	2021-03-04
66478	SUPPL	2021-03-03
66444	SUPPL	2021-03-02
66435	SUPPL	2021-03-01
66001	SUPPL	2021-01-26
65992	SUPPL	2021-01-26
63398	SUPPL	2020-06-02
63390	SUPPL	2020-06-02
56695	ORIG	2018-12-10
56424	ORIG	2018-11-13
56252	ORIG	2018-11-02