Application 020873

Type: NDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANGIOMAX	BIVALIRUDIN	INJECTABLE;INTRAVENOUS	250MG/VIAL	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
N020873-001	ANGIOMAX	BIVALIRUDIN	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020873-001	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status
N020873-001	7582727	2028-07-27	Drug product
N020873-001	7598343	2028-07-27	Drug product
N020873-001	7582727*PED	2029-01-27	Pediatric extension
N020873-001	7598343*PED	2029-01-27	Pediatric extension

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020873-001	ANGIOMAX	250MG/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2000-12-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020873-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020873-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020873-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020873-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020873-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020873-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020873-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020873-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020873-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020873-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020873-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020873-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020873-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020873-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020873-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020873-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020873-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020873-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020873-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020873-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020873-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020873-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020873-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020873-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020873-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020873-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020873-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020873-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020873-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020873-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020873-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020873-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020873-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020873-001	7582727	2028-07-27	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020873-001	7598343	2028-07-27	Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	7582727	2028-07-27	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	7598343	2028-07-27	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020873-001	7582727	2028-07-27	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020873-001	7598343	2028-07-27	Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	7582727	2028-07-27	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	7598343	2028-07-27	Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	7582727	2028-07-27	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	7598343	2028-07-27	Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	7582727	2028-07-27	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	7598343	2028-07-27	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	7582727	2028-07-27	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	7598343	2028-07-27	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	7582727	2028-07-27	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	7598343	2028-07-27	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	7582727	2028-07-27	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	7598343	2028-07-27	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020873-001	7582727	2028-07-27	Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020873-001	7598343	2028-07-27	Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020873-001	7582727*PED	2029-01-27	Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020873-001	7598343*PED	2029-01-27	Pediatric extension	`d06236e962d9…`

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	Civica, Inc.	19a4afc5-151d-4d3c-bfef-48aa8797d695	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020873 application number: NDA020873 ndc (product): 72572-035
bivalirudin	BIVALIRUDIN	Sandoz Inc	ce56f806-7845-429d-a1ce-c2dbf79b22eb	2019-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020873 application number: NDA020873 ndc (product): 0781-3158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3158	bivalirudin	bivalirudin	Sandoz	NDA AUTHORIZED GENERIC	Current
0781-3158	bivalirudin	bivalirudin	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-3447	Angiomax	bivalirudin	Sandoz Inc	NDA	Current
0781-3447	Angiomax	bivalirudin	Sandoz Inc	NDA	Current
0781-9158	bivalirudin	bivalirudin	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-9158	bivalirudin	bivalirudin	Sandoz	NDA AUTHORIZED GENERIC	Current
65293-001	Angiomax	bivalirudin	The Medicines Company	NDA	Current
65293-001	Angiomax	bivalirudin	The Medicines Company	NDA	Current
65293-001	Angiomax	bivalirudin	The Medicines Company	NDA	Current
72572-035	bivalirudin	bivalirudin	Civica, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59293	SUPPL	2019-07-10
59235	SUPPL	2019-07-05
57005	SUPPL	2018-12-26
35559	SUPPL	2016-03-22
26109	SUPPL	2016-03-22
26108	SUPPL	2013-05-22
35558	SUPPL	2013-05-21
35557	SUPPL	2010-07-01
3634	SUPPL	2010-06-29
35556	SUPPL	2005-12-05
26107	SUPPL	2005-12-05
3633	SUPPL	2005-09-08
26105	SUPPL	2005-06-15
26106	SUPPL	2004-05-07
21038	ORIG	2004-04-08
3632	SUPPL	2002-06-20
26104	ORIG	2000-12-15
13658	ORIG	2000-12-15
54031	ORIG	1900-01-01
53200	ORIG	1900-01-01
53199	ORIG	1900-01-01