Application 202360

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A202360-001	ETOMIDATE	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP		2014-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202360-001	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.

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202360-001	ETOMIDATE	2MG/ML	INJECTABLE / INJECTION	AP	2014-07-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A202360-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202360-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202360-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202360-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202360-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202360-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202360-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202360-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202360-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202360-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202360-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202360-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202360-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202360-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202360-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202360-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202360-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202360-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202360-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202360-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202360-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202360-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202360-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202360-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202360-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202360-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202360-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202360-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202360-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202360-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202360-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202360-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202360-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202360-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202360-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202360-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202360-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202360-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202360-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202360-001	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amidate	ETOMIDATE	Hospira, Inc.	b7ed5bf8-ba75-44dc-8f81-96b4ad5766be	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: ETOMIDATE
Etomidate	ETOMIDATE	Caplin Steriles Limited	9c2d0014-9e74-40b2-b452-255016c81cc1	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Amidate	ETOMIDATE	Henry Schein, Inc.	eb63c7d7-5eca-4751-be51-45cf4d7715aa	2025-10-27	Warnings, Adverse reactions	Name fallback generic name: ETOMIDATE
ETOMIDATE	ETOMIDATE	HF Acquisition Co LLC, DBA HealthFirst	9bdee875-4b48-c592-e053-2995a90a6485	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: ETOMIDATE generic name: ETOMIDATE
Etomidate	ETOMIDATE	Civica, Inc.	98002094-f065-4b5f-963f-2c34b5241316	2024-03-31	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Etomidate	ETOMIDATE	Armas Pharmaceuticals Inc.	75467058-da52-48fa-8d4e-e1025ec7d461	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Etomidate	ETOMIDATE	Hikma Pharmaceuticals USA Inc.	75bf0494-7cb9-4e8a-8edd-af62f035d236	2023-12-06	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Etomidate	ETOMIDATE	Hikma Pharmaceuticals USA Inc.	4312e3c3-34de-4cb3-8abd-c24d24a4bea1	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	2023-08-10	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	d07efb9e-5264-461d-96d8-e11fa71c5751	2023-07-27	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
ETOMIDATE	ETOMIDATE	Eugia US LLC	0820f15a-046b-4185-a2b3-2e4051ee3d82	2023-07-05	Warnings, Adverse reactions	Name fallback brand name: ETOMIDATE generic name: ETOMIDATE
Etomidate	ETOMIDATE	Mylan Institutional LLC	461e34d1-b862-4a02-9727-548c907aac48	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Etomidate generic name: ETOMIDATE
ETOMIDATE	ETOMIDATE	HF Acquisition Co LLC, DBA HealthFirst	dc43b289-4f32-1c1e-e053-2995a90a3a23	2022-04-09	Warnings, Adverse reactions	Name fallback brand name: ETOMIDATE generic name: ETOMIDATE
Etomidate	ETOMIDATE INJECTION	Fosun Pharma USA Inc	8b6c54d8-3f3f-4290-841c-976bea01086f	2019-07-28	Warnings, Adverse reactions	Name fallback brand name: Etomidate
Etomidate	ETOMIDATE INJECTION	Gland Pharma Limited	94cde4e7-3b46-419f-8dda-87675da8d89d	2017-10-17	Warnings, Adverse reactions	Name fallback brand name: Etomidate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-818	etomidate	etomidate	Zydus Lifesciences Limited	ANDA	Current
65841-818	etomidate	etomidate	Cadila Healthcare Limited	ANDA	Current
65841-818	etomidate	etomidate	Cadila Healthcare Limited	ANDA	Current
65841-818	etomidate	etomidate	Cadila Healthcare Limited	ANDA	Current
68382-545	etomidate	etomidate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-545	etomidate	etomidate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-545	etomidate	etomidate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current