Application 212018

Type: NDA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BALVERSA	ERDAFITINIB	TABLET;ORAL	3MG	Yes	No
002	BALVERSA	ERDAFITINIB	TABLET;ORAL	4MG	Yes	No
003	BALVERSA	ERDAFITINIB	TABLET;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212018-001	BALVERSA	ERDAFITINIB	3MG	TABLET / ORAL	RLD	2019-04-12
N212018-002	BALVERSA	ERDAFITINIB	4MG	TABLET / ORAL	RLD	2019-04-12
N212018-003	BALVERSA	ERDAFITINIB	5MG	TABLET / ORAL	RLD, RS	2019-04-12

Orange Book patents#

Current patent rows page 1 of 1 · 51 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212018-001	9464071	2031-04-28	U-3805		2019-05-03
N212018-001	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-001	9902714	2035-03-26		Drug product	2019-05-03
N212018-001	12037644	2035-10-18	U-3972		2024-08-15
N212018-001	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-001	11684620	2036-02-09	U-3805		2023-07-26
N212018-001	11684620	2036-02-09	U-3806		2023-07-26
N212018-001	11684620	2036-02-09	U-3807		2023-07-26
N212018-001	10478494	2036-08-13	U-3902		2024-05-10
N212018-001	11077106	2038-02-02	U-3196		2021-08-27
N212018-001	11077106	2038-02-02	U-3808		2021-08-27
N212018-002	9464071	2031-04-28	U-3805		2019-05-03
N212018-002	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-002	9902714	2035-03-26		Drug product	2019-05-03
N212018-002	12037644	2035-10-18	U-3972		2024-08-15
N212018-002	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-002	11684620	2036-02-09	U-3805		2023-07-26
N212018-002	11684620	2036-02-09	U-3806		2023-07-26
N212018-002	11684620	2036-02-09	U-3807		2023-07-26
N212018-002	10478494	2036-08-13	U-3902		2024-05-10
N212018-002	11077106	2038-02-02	U-3196		2021-08-27
N212018-002	11077106	2038-02-02	U-3808		2021-08-27
N212018-003	9464071	2031-04-28	U-3805		2019-05-03
N212018-003	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-003	9902714	2035-03-26		Drug product	2019-05-03
N212018-003	12037644	2035-10-18	U-3972		2024-08-15
N212018-003	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-003	11684620	2036-02-09	U-3805		2023-07-26
N212018-003	11684620	2036-02-09	U-3806		2023-07-26
N212018-003	11684620	2036-02-09	U-3807		2023-07-26
N212018-003	10478494	2036-08-13	U-3902		2024-05-10
N212018-003	11077106	2038-02-02	U-3196		2021-08-27
N212018-003	11077106	2038-02-02	U-3808		2021-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212018-001	I-930	2027-01-19
N212018-002	I-930	2027-01-19
N212018-003	I-930	2027-01-19

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,335 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	N212018-001	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3065	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-2518	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3805	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3807	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3806	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3805		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3807		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3806		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10478494	2036-08-13	U-3902		2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11077106	2038-02-02	U-3196		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11077106	2038-02-02	U-3808		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-2518	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3065	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3806	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3807	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3805	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3805		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3807		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3806		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10478494	2036-08-13	U-3902		2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11077106	2038-02-02	U-3196		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11077106	2038-02-02	U-3808		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212018-001	I-930	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	I-930	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	I-930	2027-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-001	I-930	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-002	I-930	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-003	I-930	2027-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212018-001	I-930	2027-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-002	I-930	2027-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-003	I-930	2027-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-001	I-930	2027-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-002	I-930	2027-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-003	I-930	2027-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-001	I-930	2027-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-002	I-930	2027-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-003	I-930	2027-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	I-930	2027-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	I-930	2027-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	I-930	2027-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	I-930	2027-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	I-930	2027-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	I-930	2027-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	I-930	2027-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	I-930	2027-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	I-930	2027-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212018-001	NCE	2024-04-12	`d06236e962d9…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BALVERSA	ERDAFITINIB	Janssen Products LP	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212018 application number: NDA212018 ndc (product): 59676-040 ndc (product): 59676-050 ndc (product): 59676-030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-030	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-030	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-030	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-030	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-030	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-040	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-040	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-040	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-040	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-040	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-050	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-050	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-050	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-050	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current
59676-050	BALVERSA	Erdafitinib	Janssen Products LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83853	SUPPL	2025-10-21
83820	SUPPL	2025-10-20
79855	SUPPL	2024-10-10
79852	SUPPL	2024-10-10
77280	SUPPL	2024-01-23
77279	SUPPL	2024-01-23
77277	SUPPL	2024-01-23
77260	SUPPL	2024-01-22
77259	SUPPL	2024-01-22
77258	SUPPL	2024-01-22
73813	SUPPL	2023-03-22
73809	SUPPL	2023-03-21
73146	SUPPL	2023-01-12
73145	SUPPL	2023-01-12
70862	SUPPL	2022-04-29
70861	SUPPL	2022-04-29
70847	SUPPL	2022-04-28
70846	SUPPL	2022-04-28
62541	SUPPL	2020-04-10
62426	SUPPL	2020-04-03
58635	ORIG	2019-05-09
58337	ORIG	2019-04-15
58312	ORIG	2019-04-12