Application 213312

Type: NDA
Sponsor: AADI BIOSCIENCE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FYARRO	SIROLIMUS ALBUMIN-BOUND NANOPARTICLES	POWDER;INTRAVENOUS	100MG/VIAL	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213312-001	FYARRO	SIROLIMUS	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2021-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17
N213312-001	10206887	2030-04-15		Drug product	2021-12-17
N213312-001	10705070	2036-03-05		Drug product	2021-12-17
N213312-001	12061183	2036-03-05		Drug product	2024-08-13
N213312-001	10973806	2036-06-29	U-3258		2021-12-17
N213312-001	12133844	2036-06-29	U-4040		2024-12-04
N213312-001	12133844	2036-06-29	U-4041		2024-12-04
N213312-001	12133844	2036-06-29	U-4042		2024-12-04
N213312-001	11497737	2040-10-28		Drug product	2022-11-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213312-001	ODE-386	2028-11-22

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213312-001	FYARRO	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-11-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 196 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	10206887	2030-04-15		Drug product	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	10705070	2036-03-05		Drug product	2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	12061183	2036-03-05		Drug product	2024-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	10973806	2036-06-29	U-3258		2021-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	12133844	2036-06-29	U-4040		2024-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	12133844	2036-06-29	U-4041		2024-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	12133844	2036-06-29	U-4042		2024-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213312-001	11497737	2040-10-28		Drug product	2022-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	10206887	2030-04-15		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	10705070	2036-03-05		Drug product	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	12061183	2036-03-05		Drug product	2024-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	10973806	2036-06-29	U-3258		2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	12133844	2036-06-29	U-4040		2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	12133844	2036-06-29	U-4041		2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	12133844	2036-06-29	U-4042		2024-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213312-001	11497737	2040-10-28		Drug product	2022-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	10206887	2030-04-15		Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	10705070	2036-03-05		Drug product	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	12061183	2036-03-05		Drug product	2024-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	10973806	2036-06-29	U-3258		2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	12133844	2036-06-29	U-4040		2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	12133844	2036-06-29	U-4041		2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	12133844	2036-06-29	U-4042		2024-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	11497737	2040-10-28		Drug product	2022-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	10206887	2030-04-15		Drug product	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	10705070	2036-03-05		Drug product	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	12061183	2036-03-05		Drug product	2024-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	10973806	2036-06-29	U-3258		2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	12133844	2036-06-29	U-4040		2024-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	12133844	2036-06-29	U-4041		2024-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	12133844	2036-06-29	U-4042		2024-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213312-001	11497737	2040-10-28		Drug product	2022-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	8911786	2029-02-14	U-3259	Drug product	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	10206887	2030-04-15		Drug product	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	10705070	2036-03-05		Drug product	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	12061183	2036-03-05		Drug product	2024-08-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213312-001	ODE-386	2028-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213312-001	ODE-386	2028-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213312-001	ODE-386	2028-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213312-001	ODE-386	2028-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213312-001	ODE-386	2028-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213312-001	ODE-386	2028-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213312-001	NP	2024-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213312-001	ODE-386	2028-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213312-001	NP	2024-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213312-001	ODE-386	2028-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213312-001	NP	2024-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213312-001	ODE-386	2028-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213312-001	NP	2024-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213312-001	ODE-386	2028-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213312-001	NP	2024-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213312-001	ODE-386	2028-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213312-001	NP	2024-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213312-001	ODE-386	2028-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213312-001	NP	2024-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213312-001	ODE-386	2028-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213312-001	NP	2024-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213312-001	ODE-386	2028-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213312-001	NP	2024-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213312-001	ODE-386	2028-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213312-001	NP	2024-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213312-001	NP	2024-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213312-001	NP	2024-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213312-001	NP	2024-11-22	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213312-001	NP	2024-11-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213312-001	ODE-386	2028-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213312-001	NP	2024-11-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213312-001	ODE-386	2028-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213312-001	NP	2024-11-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213312-001	ODE-386	2028-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213312-001	NP	2024-11-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213312-001	ODE-386	2028-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213312-001	NP	2024-11-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213312-001	ODE-386	2028-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213312-001	NP	2024-11-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213312-001	ODE-386	2028-11-22	`a67488948f0b…`

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
FYARRO	SIROLIMUS	Aadi Bioscience, Inc.	0f9bb784-53e2-46f9-a65d-1c6c2a230eaf	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213312 application number: NDA213312 ndc (product): 80803-153

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80803-153	FYARRO	Sirolimus	Aadi Bioscience	NDA	Current
80803-153	FYARRO	Sirolimus	Aadi Bioscience	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71970	ORIG	2022-08-30
69408	ORIG	2021-11-24
69383	ORIG	2021-11-23