Application 215331

Type: NDA
Sponsor: MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BORTEZOMIB	BORTEZOMIB	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	3.5MG/3.5ML/VIAL	No	No
002	BORTEZOMIB	BORTEZOMIB	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	3.5MG/1.4ML/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N215331-001	BORTEZOMIB	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2022-07-27
N215331-002	BORTEZOMIB	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2022-07-27

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
N215331-001	11679119	2042-09-23	U-3632		2023-06-27
N215331-001	11679119	2042-09-23	U-3633		2023-06-27
N215331-001	11752164	2042-09-23	U-3632		2023-09-28
N215331-001	11752164	2042-09-23	U-3633		2023-09-28
N215331-001	12005069	2042-09-23		Drug product	2024-06-20
N215331-002	11679119	2042-09-23	U-3632		2023-06-27
N215331-002	11679119	2042-09-23	U-3633		2023-06-27
N215331-002	11752164	2042-09-23	U-3632		2023-09-28
N215331-002	11752164	2042-09-23	U-3633		2023-09-28
N215331-002	12005069	2042-09-23		Drug product	2024-06-20

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 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-27	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215331-001	BORTEZOMIB	3.5MG/3.5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215331-002	BORTEZOMIB	3.5MG/1.4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215331-001	11679119	2042-09-23	U-3632		2023-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-001	11679119	2042-09-23	U-3633		2023-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-001	11752164	2042-09-23	U-3632		2023-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-001	11752164	2042-09-23	U-3633		2023-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-001	12005069	2042-09-23		Drug product	2024-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-002	11679119	2042-09-23	U-3632		2023-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-002	11679119	2042-09-23	U-3633		2023-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-002	11752164	2042-09-23	U-3632		2023-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-002	11752164	2042-09-23	U-3633		2023-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215331-002	12005069	2042-09-23		Drug product	2024-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215331-001	11679119	2042-09-23	U-3632		2023-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-001	11679119	2042-09-23	U-3633		2023-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-001	11752164	2042-09-23	U-3632		2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-001	11752164	2042-09-23	U-3633		2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-001	12005069	2042-09-23		Drug product	2024-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-002	11679119	2042-09-23	U-3632		2023-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-002	11679119	2042-09-23	U-3633		2023-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-002	11752164	2042-09-23	U-3632		2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-002	11752164	2042-09-23	U-3633		2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215331-002	12005069	2042-09-23		Drug product	2024-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215331-001	11679119	2042-09-23	U-3632		2023-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-001	11679119	2042-09-23	U-3633		2023-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-001	11752164	2042-09-23	U-3632		2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-001	11752164	2042-09-23	U-3633		2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-001	12005069	2042-09-23		Drug product	2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-002	11679119	2042-09-23	U-3632		2023-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-002	11679119	2042-09-23	U-3633		2023-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-002	11752164	2042-09-23	U-3632		2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-002	11752164	2042-09-23	U-3633		2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215331-002	12005069	2042-09-23		Drug product	2024-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-001	11679119	2042-09-23	U-3632		2023-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-001	11679119	2042-09-23	U-3633		2023-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-001	11752164	2042-09-23	U-3632		2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-001	11752164	2042-09-23	U-3633		2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-001	12005069	2042-09-23		Drug product	2024-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-002	11679119	2042-09-23	U-3632		2023-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-002	11679119	2042-09-23	U-3633		2023-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-002	11752164	2042-09-23	U-3632		2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-002	11752164	2042-09-23	U-3633		2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215331-002	12005069	2042-09-23		Drug product	2024-06-20	`31067a03dcf5…`

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
Bortezomib	BORTEZOMIB	MAIA Pharmaceuticals, Inc.	c40e6a28-d577-43d4-bca6-bef28da1d580	2021-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215331 application number: NDA215331 ndc (product): 70511-161 ndc (product): 70511-162

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70511-161	Bortezomib	bortezomib	MAIA Pharmaceuticals, Inc.	NDA	Current
70511-162	Bortezomib	bortezomib	MAIA Pharmaceuticals, Inc.	NDA	Current
72266-243	Bortezomib	bortezomib	FOSUN PHARMA USA INC	NDA	Current
72266-244	Bortezomib	bortezomib	FOSUN PHARMA USA INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74617	ORIG	2023-06-23
71660	ORIG	2022-07-28
71655	ORIG	2022-07-28