Application 090816

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIVALIRUDIN	BIVALIRUDIN	INJECTABLE;INTRAVENOUS	250MG/VIAL	No	No

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
A090816-001	BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS			2015-07-14

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090816-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A090816-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090816-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090816-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090816-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090816-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090816-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090816-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090816-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090816-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090816-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090816-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090816-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090816-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090816-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090816-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090816-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090816-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090816-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090816-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090816-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090816-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090816-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090816-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090816-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090816-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090816-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090816-001	AP	1	`cb3db0bc1861…`

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

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
0409-8300	Bivalirudin	BIVALIRUDIN	Hospira, Inc.	ANDA	Current
0409-8300	Bivalirudin	BIVALIRUDIN	Hospira, Inc.	ANDA	Current
0409-8300	Bivalirudin	BIVALIRUDIN	Hospira, Inc.	ANDA	Current
0409-8300	Bivalirudin	BIVALIRUDIN	Hospira, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39612	ORIG	2015-07-16
31498	ORIG	2015-07-15