Application 203985

Type: NDA
Sponsor: NOVARTIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;ORAL	2MG	Yes	No
002	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;ORAL	3MG	Yes	No
003	AFINITOR DISPERZ	EVEROLIMUS	TABLET, FOR SUSPENSION;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	TE codes	RLD / RS	Approval date
N203985-001	AFINITOR DISPERZ	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29
N203985-002	AFINITOR DISPERZ	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29
N203985-003	AFINITOR DISPERZ	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203985-001	AB
N203985-002	AB
N203985-003	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203985-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203985-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 348 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	ODE-169	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	ODE-169	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	ODE-169	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	ODE-169	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	ODE-169	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	ODE-169	2025-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	ODE-169	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	ODE-169	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	ODE-169	2025-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	ODE-169	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	ODE-169	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	ODE-169	2025-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	ODE-169	2025-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	ODE-169	2025-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	ODE-169	2025-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	ODE-169	2025-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	ODE-169	2025-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	ODE-169	2025-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	ODE-169	2025-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	ODE-169	2025-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	ODE-169	2025-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-002	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-003	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203985-001	ODE-169	2025-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203985-002	ODE-169	2025-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203985-003	ODE-169	2025-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	ODE-169	2025-04-10	`5c6f7cd8ea54…`

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
Afinitor	EVEROLIMUS	Novartis Pharmaceuticals Corporation	2150f73a-179b-4afc-b8ce-67c85cc72f04	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203985 application number: NDA203985 ndc (product): 0078-0628 ndc (product): 0078-0626 ndc (product): 0078-0627

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0626	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0627	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0628	Afinitor	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78399	SUPPL	2024-05-06
78397	SUPPL	2024-05-06
70062	SUPPL	2022-02-03
70046	SUPPL	2022-02-02
67111	SUPPL	2021-04-19
67104	SUPPL	2021-04-19
61897	SUPPL	2020-02-14
61892	SUPPL	2020-02-14
61630	SUPPL	2020-01-23
61625	SUPPL	2020-01-23
53648	SUPPL	2018-04-11
40337	SUPPL	2016-02-02
10267	SUPPL	2016-02-01
19509	SUPPL	2015-01-29
10266	SUPPL	2015-01-26
10265	SUPPL	2014-07-03
19508	SUPPL	2014-07-02
40336	SUPPL	2014-02-21
40334	SUPPL	2014-02-21
32487	SUPPL	2014-02-21
32485	SUPPL	2014-02-21
19507	SUPPL	2014-02-21
10264	SUPPL	2014-02-21
44891	ORIG	2013-11-12
22939	ORIG	2013-11-12
40335	SUPPL	2013-11-08
32486	SUPPL	2013-11-07
10263	ORIG	2012-08-31
19506	ORIG	2012-08-29
58107	ORIG	1900-01-01
51099	ORIG	1900-01-01
51098	ORIG	1900-01-01
51097	ORIG	1900-01-01