Application 205962

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A205962-001	BIVALIRUDIN	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS			2018-07-27

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 · 42 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
2026-08-18 06:07:40	2026-07	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2018-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2018-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS		2018-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205962-001	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2018-07-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A205962-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205962-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205962-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205962-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205962-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205962-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205962-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205962-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205962-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205962-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205962-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205962-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205962-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205962-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205962-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205962-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205962-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205962-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205962-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205962-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205962-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205962-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205962-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205962-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205962-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205962-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205962-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205962-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205962-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205962-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205962-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205962-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205962-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205962-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205962-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205962-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205962-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205962-001	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 · 1 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	Exact identifier application applno (ANDA): 205962 application number: ANDA205962 ndc (product): 55150-210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55150-210	BIVALIRUDIN	BIVALIRUDIN	AuroMedics Pharma LLC	ANDA	Current
55150-210	BIVALIRUDIN	BIVALIRUDIN	AuroMedics Pharma LLC	ANDA	Current
55150-210	BIVALIRUDIN	BIVALIRUDIN	AuroMedics Pharma LLC	ANDA	Current
55150-210	BIVALIRUDIN	BIVALIRUDIN	AuroMedics Pharma LLC	ANDA	Current
55150-210	BIVALIRUDIN	BIVALIRUDIN	AuroMedics Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32770	ORIG	2015-12-31