Application 215028

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETOMIDATE	ETOMIDATE	INJECTABLE;INJECTION	2MG/ML	No	No

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
A215028-001	ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP		2020-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215028-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215028-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215028-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215028-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215028-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215028-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215028-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215028-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215028-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215028-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215028-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215028-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215028-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215028-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215028-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215028-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215028-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215028-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215028-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215028-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215028-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A215028-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A215028-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215028-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215028-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215028-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215028-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215028-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215028-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215028-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215028-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215028-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215028-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215028-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215028-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215028-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215028-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etomidate	ETOMIDATE	Caplin Steriles Limited	9c2d0014-9e74-40b2-b452-255016c81cc1	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028 ndc (product): 65145-128 ndc (product): 65145-127
Etomidate	ETOMIDATE	Armas Pharmaceuticals Inc.	75467058-da52-48fa-8d4e-e1025ec7d461	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028 ndc (product): 65219-445
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	d07efb9e-5264-461d-96d8-e11fa71c5751	2023-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028 ndc (product): 65219-447 ndc (product): 65219-445

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-674	etomidate	etomidate	Sagent Pharmaceuticals	ANDA	Current
25021-674	etomidate	etomidate	Sagent Pharmaceuticals	ANDA	Current
65145-127	Etomidate	Etomidate	Caplin Steriles Limited	ANDA	Current
65145-128	Etomidate	Etomidate	Caplin Steriles Limited	ANDA	Current
65219-445	Etomidate	Etomidate	Fresenius Kabi USA, LLC	ANDA	Current
65219-447	Etomidate	Etomidate	Fresenius Kabi USA, LLC	ANDA	Current