Application 208374

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN	SOLUTION;INTRAVENOUS	250MG/50ML (5MG/ML)	Yes	Yes
002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN	SOLUTION;INTRAVENOUS	500MG/100ML (5MG/ML)	Yes	Yes

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

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
N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21
N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	BIVALIRUDIN	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21

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 3 · 84 observed 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	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2017-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208374-001	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	250MG/50ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208374-002	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-12-21	`bb7c543d1eb4…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIVALIRUDIN	BIVALIRUDIN	Eugia US LLC	e574d04f-67b4-4a84-9d66-8c2d54f95120	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
bivalirudin	BIVALIRUDIN	Civica, Inc.	19a4afc5-151d-4d3c-bfef-48aa8797d695	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Fresenius Kabi USA, LLC	50975be1-6d1f-497c-b989-1825a0fae1a7	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Fresenius Kabi USA, LLC	af943fa0-ab0f-4b62-9ff0-54ee24cdb772	2025-05-08	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Mylan Institutional LLC	95d150e7-f152-4091-b831-e469c9578a54	2025-03-24	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	61de12ff-e280-4bab-9804-43869ec45fa7	2024-12-23	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Accord Healthcare, Inc.	c20969cb-72d4-469b-9bd8-332250d896c3	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	MAIA Pharmaceuticals, Inc.	c727199d-f4cd-4658-8fdf-568590beface	2024-05-27	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
BIVALIRUDIN	BIVALIRUDIN	Meitheal Pharmaceuticals Inc.	26fb46f6-0088-42b8-b6f2-c67224776803	2024-04-04	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Par Health USA, LLC	91cf9d00-29e0-4357-a184-f70026c47edb	2024-03-01	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Avenacy, Inc.	42aa2630-83d6-433d-8277-0f672cf8d71d	2023-10-20	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
bivalirudin	BIVALIRUDIN	Slate Run Pharmaceuticals, LLC	5d9a45c6-e234-4d56-9132-5e24e65852e6	2021-06-09	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
BIVALIRUDIN	BIVALIRUDIN	Meitheal Pharmaceuticals Inc.	4119b710-ef30-4e3e-b99a-38e42b4b3fca	2021-06-08	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
bivalirudin	BIVALIRUDIN	Sandoz Inc	ce56f806-7845-429d-a1ce-c2dbf79b22eb	2019-09-30	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN
Bivalirudin	BIVALIRUDIN	Dr. Reddy's Laboratories Limited	19beb2ae-6064-3c24-fe50-0cee86896979	2019-07-16	Warnings, Adverse reactions	Name fallback generic name: BIVALIRUDIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-9572	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9572	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9572	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9572	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9576	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9576	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9576	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current
0338-9576	Bivalirudin in 0.9% Sodium Chloride	Bivalirudin in 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65891	SUPPL	2021-01-12
65872	SUPPL	2021-01-08
52671	ORIG	2018-02-20
50918	ORIG	2017-12-27
50865	ORIG	2017-12-26