Application 020883

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARGATROBAN	ARGATROBAN	INJECTABLE;INJECTION	250MG/2.5ML (100MG/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
N020883-001	ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30

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	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION		RLD	2000-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020883-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-06-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020883-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020883-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020883-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020883-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020883-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020883-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020883-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020883-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020883-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020883-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020883-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020883-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020883-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020883-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020883-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020883-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020883-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020883-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020883-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020883-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020883-001	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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Argatroban	ARGATROBAN	Plano Pharmaceuticals Inc.	514ad15b-d060-9d65-e063-6294a90a6188	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Sagent Pharmaceuticals	629aee90-3bf3-4947-a978-21cbba2e1c41	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Mullan Pharmaceutical Inc.	546484ed-afab-b47b-e063-6394a90aa52d	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Mullan Pharmaceutical Inc.	50e21062-f021-40f2-ad11-896f46378a15	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Gland Pharma Limited	270dbb59-e080-4a64-91d9-a68bed4bd2e5	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
ARGATROBAN	ARGATROBAN	Accord Healthcare Inc.	46cdf9e6-839c-49c8-9ee1-c30cfdd9368d	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: ARGATROBAN generic name: ARGATROBAN
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	0cdf3f67-5bf3-4d58-b330-03febdc652bf	2026-05-03	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
ARGATROBAN	ARGATROBAN	Caplin Steriles Limited	b5143563-ff45-433a-a9e2-f8b8340db1f5	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: ARGATROBAN generic name: ARGATROBAN
Argatroban	ARGATROBAN	Gland Pharma Limited	e5ccb93c-f411-4e7e-824a-4a592b4947ec	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Fresenius Kabi USA, LLC	dfa5d325-f609-4c9a-aaae-1a17df47da1e	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Mylan Institutional LLC	b0dedf95-8395-46bf-b94a-dcf2dd085942	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	41f56fe7-4824-4032-aa73-cfb4f8db2252	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	79eec27d-ac63-4996-8b1a-c2cd52ad2b2c	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Eugia US LLC	d9b975bd-e3f4-466e-96ca-7bef7899506d	2023-08-03	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Par Health USA, LLC	1a67a87d-59cb-414c-a11e-ab8f0a9bb778	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Par Health USA, LLC	d4e5238f-2378-424e-bda2-f1a2cf874041	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN
Argatroban	ARGATROBAN	Amneal Pharmaceuticals LLC	dedef330-555a-46b7-b1d6-0838b4cd9651	2019-05-23	Warnings, Adverse reactions	Name fallback brand name: Argatroban generic name: ARGATROBAN

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
0078-0930	ARGATROBAN	argatroban	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0930	ARGATROBAN	argatroban	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0930	ARGATROBAN	argatroban	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0930	ARGATROBAN	argatroban	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49363	SUPPL	2017-08-15
49290	SUPPL	2017-08-09
35569	SUPPL	2016-06-01
26122	SUPPL	2016-05-27
13666	SUPPL	2014-03-11
3647	SUPPL	2014-03-11
24183	SUPPL	2008-07-16
13665	SUPPL	2008-05-19
26121	SUPPL	2008-05-08
26120	SUPPL	2005-09-08
3646	SUPPL	2005-04-12
3645	SUPPL	2003-11-13
21040	ORIG	2002-04-05
35568	SUPPL	2002-04-03
26119	SUPPL	2002-04-03
13664	ORIG	2000-06-30
3644	ORIG	2000-06-30
53180	ORIG	1900-01-01
53179	ORIG	1900-01-01