Application 021560

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.25MG	Yes	No
002	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.5MG	Yes	No
003	ZORTRESS	EVEROLIMUS	TABLET;ORAL	0.75MG	Yes	Yes
004	ZORTRESS	EVEROLIMUS	TABLET;ORAL	1MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021560-001	ZORTRESS	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20
N021560-002	ZORTRESS	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20
N021560-003	ZORTRESS	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20
N021560-004	ZORTRESS	EVEROLIMUS	1MG	TABLET / ORAL	AB	RLD	2018-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021560-001	AB
N021560-002	AB
N021560-003	AB
N021560-004	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 2 of 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021560-001	ZORTRESS	0.25MG	TABLET / ORAL	AB	RLD	2010-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021560-002	ZORTRESS	0.5MG	TABLET / ORAL	AB	RLD	2010-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021560-003	ZORTRESS	0.75MG	TABLET / ORAL	AB	RLD	2010-04-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021560-004	ZORTRESS	1MG	TABLET / ORAL	AB	RLD, RS	2018-08-10	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021560-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021560-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021560-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021560-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021560-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021560-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021560-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021560-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021560-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021560-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021560-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021560-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021560-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021560-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021560-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021560-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021560-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021560-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021560-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021560-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021560-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021560-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021560-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021560-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021560-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021560-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021560-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021560-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021560-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021560-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021560-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021560-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021560-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021560-001	5665772	2019-09-09	U-1049	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-001	5665772	2019-09-09	U-1365	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-002	5665772	2019-09-09	U-1049	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-002	5665772	2019-09-09	U-1365	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-003	5665772	2019-09-09	U-1365	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-003	5665772	2019-09-09	U-1049	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021560-003	5665772*PED	2020-03-09		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021560-003	5665772*PED	2020-03-09		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021560-003	5665772*PED	2020-03-09		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021560-001	5665772	2019-09-09	U-1049	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-001	5665772	2019-09-09	U-1365	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-002	5665772	2019-09-09	U-1049	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-002	5665772	2019-09-09	U-1365	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-003	5665772	2019-09-09	U-1365	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-003	5665772	2019-09-09	U-1049	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021560-003	5665772*PED	2020-03-09		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021560-001	5665772	2019-09-09	U-1049	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-001	5665772	2019-09-09	U-1365	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-002	5665772	2019-09-09	U-1049	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-002	5665772	2019-09-09	U-1365	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-003	5665772	2019-09-09	U-1365	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-003	5665772	2019-09-09	U-1049	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021560-003	5665772*PED	2020-03-09		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021560-001	5665772	2019-09-09	U-1365	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-001	5665772	2019-09-09	U-1049	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-001	5665772*PED	2020-03-09		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-002	5665772	2019-09-09	U-1365	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-002	5665772	2019-09-09	U-1049	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-002	5665772*PED	2020-03-09		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021560-003	5665772	2019-09-09	U-1365	Drug substance, Drug product	`ea99ee380514…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	i3 Pharmaceuticals, LLC	be5da0fd-8fd4-4f84-a307-f270048d503c	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Biocon Pharma Inc.	5b809dfe-c076-07c5-207e-178c3f0d32d3	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	Amneal Pharmaceuticals NY LLC	6f1ae129-c21e-4c25-84c1-a6757d9a7eb2	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
TORPENZ	EVEROLIMUS	Upsher-Smith Laboratories, LLC	4c0075dd-a0a8-4dc4-be32-1be8383fbbdc	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Afinitor	EVEROLIMUS	Novartis Pharmaceuticals Corporation	2150f73a-179b-4afc-b8ce-67c85cc72f04	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Yulithira	EVEROLIMUS	CivicaScript, LLC	5e325efa-8ae6-4dac-b59b-d7c74c73186c	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
everolimus	EVEROLIMUS	Novugen Pharma (USA) LLC.	67e62e26-448d-46ec-b5a1-00dc1b5e26c6	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
everolimus	EVEROLIMUS	Aurobindo Pharma Limited	43ef3c29-0e25-4fdd-aea1-06a20af9bbab	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Ascend Laboratories, LLC	2693c497-a70b-4d00-b6db-602c872e5bed	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Natco Pharma Limited	d44998bb-5deb-4ee7-a0a5-979fe3f49557	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Breckenridge Pharmaceutical, Inc.	01f7b5fb-be0d-4adf-acd2-6899018de966	2025-09-05	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Biocon Pharma Inc.	435da284-ef0e-ca90-e0db-bab9382922e0	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	Biocon Pharma Inc.	5fb55800-f322-6bb6-9dde-622925ef28bd	2025-03-21	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	cf2dd54b-7a1d-4401-9a01-75e68235e433	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
EVEROLIMUS	EVEROLIMUS	NorthStar RxLLC	5cfca904-b75c-5a39-8cb9-b99bb421bceb	2024-08-02	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS
Everolimus	EVEROLIMUS	Natco Pharma Limited	e3dbbc24-7e55-4069-a305-e2cded2db641	2023-06-08	Warnings, Adverse reactions	Name fallback generic name: EVEROLIMUS

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 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0414	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0415	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0417	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0422	Zortress	everolimus	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77673	SUPPL	2024-02-29
77672	SUPPL	2024-02-29
75497	SUPPL	2023-09-15
75473	SUPPL	2023-09-15
74478	SUPPL	2023-06-13
64271	SUPPL	2020-08-12
64270	SUPPL	2020-08-12
64269	SUPPL	2020-08-12
51079	SUPPL	2018-01-18
51078	SUPPL	2018-01-18
51068	SUPPL	2018-01-17
51060	SUPPL	2018-01-17
45622	SUPPL	2016-10-17
45546	SUPPL	2016-10-14
37226	SUPPL	2015-11-12
5738	SUPPL	2015-11-09
37225	SUPPL	2015-01-30
28116	SUPPL	2015-01-28
15777	SUPPL	2013-02-20
5734	SUPPL	2013-02-20
37224	SUPPL	2012-10-04
5736	SUPPL	2012-10-04
5737	SUPPL	2012-05-04
37223	SUPPL	2012-05-01
5735	SUPPL	2012-04-27
28115	SUPPL	2011-11-28
24205	ORIG	2010-06-16
21734	ORIG	2010-06-16
37222	ORIG	2010-05-03
28114	ORIG	2010-04-29