Application 020718

Type: NDA
Sponsor: SCHERING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTEGRILIN	EPTIFIBATIDE	INJECTABLE;INJECTION	2MG/ML	Yes	Yes
002	INTEGRILIN	EPTIFIBATIDE	INJECTABLE;INJECTION	75MG/100ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020718-001	INTEGRILIN	EPTIFIBATIDE	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18
N020718-002	INTEGRILIN	EPTIFIBATIDE	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18

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 · 84 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
2026-08-18 06:07:40	2026-07	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020718-001	INTEGRILIN	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020718-002	INTEGRILIN	75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1998-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020718-001	INTEGRILIN	2MG/ML	INJECTABLE / INJECTION		RLD	1998-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020718-002	INTEGRILIN	75MG/100ML	INJECTABLE / INJECTION		RLD	1998-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020718-001	INTEGRILIN	2MG/ML	INJECTABLE / INJECTION		RLD	1998-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020718-002	INTEGRILIN	75MG/100ML	INJECTABLE / INJECTION		RLD	1998-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020718-001	INTEGRILIN	2MG/ML	INJECTABLE / INJECTION		RLD	1998-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020718-002	INTEGRILIN	75MG/100ML	INJECTABLE / INJECTION		RLD	1998-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020718-001	INTEGRILIN	2MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020718-002	INTEGRILIN	75MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1998-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020718-001	INTEGRILIN	2MG/ML	INJECTABLE / INJECTION		RLD	1998-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020718-002	INTEGRILIN	75MG/100ML	INJECTABLE / INJECTION		RLD	1998-05-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020718-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020718-002	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020718-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020718-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020718-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020718-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020718-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020718-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020718-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020718-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020718-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020718-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020718-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020718-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020718-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020718-002	AP	1	`ea99ee380514…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eptifibatide	EPTIFIBATIDE	Slate Run Pharmaceuticals, LLC	da421d88-6c00-428a-82a6-b3b4f7a68b85	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Slate Run Pharmaceuticals, LLC	2ab98ecd-c578-4032-a3d5-ae14d58d86a7	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	c488f1af-a82c-4360-8886-79520635561a	2025-10-20	Warnings	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Avenacy, LLC	c0781dae-3ef6-4cab-b084-01d2e45f3764	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
eptifibatide	EPTIFIBATIDE	Sagent Pharmaceuticals	a0d18778-0194-461a-a4ea-b2fca5df57c3	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Baxter Healthcare Company	5f46b76b-5c83-49b9-ada8-4ad5cf81a38c	2024-05-29	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Meitheal Pharmaceuticals Inc.	3e7e7cd3-8efa-4d91-a5ab-7fd78b0cc65e	2024-05-14	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Eugia US LLC	00ad7bbe-cadd-4647-b74b-adfc9f2b5e94	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Mylan Institutional LLC	a7a89c59-22fb-41fd-b70a-ac2395717db1	2021-05-28	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE
Eptifibatide	EPTIFIBATIDE	Mylan Institutional LLC	88a37f9c-496b-4a6b-9665-4550abba04f1	2021-05-28	Warnings, Adverse reactions	Name fallback generic name: EPTIFIBATIDE

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
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1136	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current
0085-1177	Integrilin	Eptifibatide	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66440	SUPPL	2021-03-02
66418	SUPPL	2021-03-01
3201	SUPPL	2013-03-26
35225	SUPPL	2013-03-25
3200	SUPPL	2011-04-04
35224	SUPPL	2011-04-01
35223	SUPPL	2009-01-02
25629	SUPPL	2008-12-19
35222	SUPPL	2005-10-14
3199	SUPPL	2005-10-14
3198	SUPPL	2004-07-21
35221	SUPPL	2003-06-22
3197	SUPPL	2003-06-22
35220	SUPPL	2001-06-08
35219	SUPPL	2001-06-08
25628	SUPPL	2001-06-08
20878	SUPPL	2001-06-08
20877	SUPPL	2001-06-08
3196	SUPPL	2001-06-08
41613	SUPPL	1999-09-20
35218	SUPPL	1999-09-20
25627	SUPPL	1999-09-20
35217	ORIG	1998-05-18
20876	ORIG	1998-05-18
3195	ORIG	1998-05-18