Application 203049

Type: NDA
Sponsor: HIKMA PHARM CO LTD

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
002	ARGATROBAN	ARGATROBAN	INJECTABLE;INJECTION	50MG/50ML (1MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203049-001	ARGATROBAN	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05
N203049-002	ARGATROBAN	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N203049-001	AP
N203049-002	AP

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 · 82 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	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP		2012-01-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION		RLD, RS	2016-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203049-001	ARGATROBAN	250MG/2.5ML (100MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2012-01-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203049-002	ARGATROBAN	50MG/50ML (1MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2016-09-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	N203049-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203049-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203049-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203049-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203049-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203049-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203049-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203049-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203049-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203049-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203049-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203049-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203049-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203049-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203049-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203049-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203049-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203049-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203049-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203049-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203049-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203049-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203049-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203049-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203049-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203049-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203049-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203049-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203049-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203049-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203049-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203049-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203049-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203049-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203049-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203049-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203049-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203049-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203049-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203049-001	AP	1	`87673890dc5c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	0cdf3f67-5bf3-4d58-b330-03febdc652bf	2026-05-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203049 application number: NDA203049 ndc (product): 0143-9559 ndc (product): 0143-9674
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	41f56fe7-4824-4032-aa73-cfb4f8db2252	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203049 application number: NDA203049 ndc (product): 0143-9377
Argatroban	ARGATROBAN	Hikma Pharmaceuticals USA Inc.	79eec27d-ac63-4996-8b1a-c2cd52ad2b2c	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203049 application number: NDA203049 ndc (product): 0143-9288

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9288	Argatroban	Argatroban	West-Ward Pharmaceuticals Corp	NDA	Current
0143-9288	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9288	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9377	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9377	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9377	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9559	Argatroban	Argatroban	West-Ward Pharmaceuticals Corp	NDA	Current
0143-9559	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9559	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9559	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9559	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9674	Argatroban	Argatroban	West-Ward Pharmaceuticals Corp	NDA	Current
0143-9674	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9674	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9674	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9674	Argatroban	Argatroban	Hikma Pharmaceuticals USA Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85969	SUPPL	2026-05-19
85961	SUPPL	2026-05-19
62650	SUPPL	2020-04-23
62645	SUPPL	2020-04-23
48862	SUPPL	2017-06-29
45582	SUPPL	2016-10-06
45448	SUPPL	2016-10-03
19414	SUPPL	2016-06-01
32362	SUPPL	2016-05-27
24424	ORIG	2013-06-04
22907	ORIG	2013-06-04
32361	ORIG	2012-01-09
40254	ORIG	2012-01-06