Application 203258

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPTIFIBATIDE	EPTIFIBATIDE	INJECTABLE;INJECTION	2MG/ML	No	No
002	EPTIFIBATIDE	EPTIFIBATIDE	INJECTABLE;INJECTION	75MG/100ML	No	No

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
A203258-001	EPTIFIBATIDE	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20
A203258-002	EPTIFIBATIDE	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203258-001	AP
A203258-002	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 · 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	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP		2018-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP		2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203258-001	EPTIFIBATIDE	2MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203258-002	EPTIFIBATIDE	75MG/100ML	INJECTABLE / INJECTION	AP	RS	2018-07-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203258-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203258-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203258-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203258-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203258-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203258-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203258-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203258-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203258-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203258-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203258-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203258-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203258-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203258-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203258-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203258-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203258-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203258-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203258-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203258-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203258-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203258-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203258-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203258-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203258-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203258-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203258-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203258-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203258-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203258-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203258-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203258-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203258-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203258-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203258-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203258-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203258-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203258-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203258-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203258-002	AP	1	`bb7c543d1eb4…`

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
Eptifibatide	EPTIFIBATIDE	Mylan Institutional LLC	a7a89c59-22fb-41fd-b70a-ac2395717db1	2021-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203258 application number: ANDA203258 ndc (product): 72078-027 ndc (product): 72078-025 ndc (product): 72078-026
Eptifibatide	EPTIFIBATIDE	Mylan Institutional LLC	88a37f9c-496b-4a6b-9665-4550abba04f1	2021-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203258 application number: ANDA203258 ndc (product): 67457-630 ndc (product): 67457-629 ndc (product): 67457-631

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-629	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
67457-629	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
67457-630	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
67457-630	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
67457-631	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
67457-631	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-025	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-025	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-025	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-026	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-026	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-026	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-027	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-027	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current
72078-027	Eptifibatide	eptifibatide	Mylan Institutional LLC	ANDA	Current