Application 211215

Type: NDA
Sponsor: MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANGIOMAX RTU	BIVALIRUDIN	SOLUTION;INTRAVENOUS	250MG/50ML (5MG/ML)	Yes	Yes

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

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
N211215-001	ANGIOMAX RTU	BIVALIRUDIN	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-07-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211215-001	11903993	2039-05-20	U-3817		2024-02-21
N211215-001	11918622	2039-05-20	U-3817		2024-03-06
N211215-001	11992514	2039-05-20		Drug product	2024-05-30
N211215-001	12472224	2039-05-20	U-3817	Drug product	2025-11-20

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.

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	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211215-001	ANGIOMAX RTU	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-07-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 49 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	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211215-001	12472224	2039-05-20	U-3817	Drug product	2025-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211215-001	12472224	2039-05-20	U-3817	Drug product	2025-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211215-001	11992514	2039-05-20		Drug product	2024-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211215-001	11903993	2039-05-20	U-3817		2024-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211215-001	11918622	2039-05-20	U-3817		2024-03-06	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bivalirudin	BIVALIRUDIN	MAIA Pharmaceuticals, Inc.	c727199d-f4cd-4658-8fdf-568590beface	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211215 application number: NDA211215
Bivalirudin	BIVALIRUDIN	Par Health USA, LLC	91cf9d00-29e0-4357-a184-f70026c47edb	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211215 application number: NDA211215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70511-141	bivalirudin	bivalirudin	MAIA Pharmaceuticals, Inc.	NDA	Current
70511-141	Angiomax RTU	bivalirudin	MAIA Pharmaceuticals, Inc.	NDA	Current
70860-403	Bivalirudin	bivalirudin	Athenex Pharmaceutical Division, LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74209	SUPPL	2023-05-10
74204	SUPPL	2023-05-10
62107	ORIG	2020-03-10
59499	ORIG	2019-07-30
59473	ORIG	2019-07-26