Application 078945

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION			2013-01-03

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 · 43 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
2026-09-14 22:38:34	2026-08	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2013-01-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078945-001	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2013-01-03	`f41ea6bd6efb…`

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	A078945-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078945-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078945-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078945-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078945-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078945-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078945-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078945-001	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 4 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	3aeb533a-e72c-4af8-9867-b71d2eba9a49	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	115e8fb5-61f5-4719-8eb3-063b7ca194ae	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	d6694136-7591-4f23-8415-f2aa3c8bab40	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b406d22-f1bf-460d-e063-6294a90a6b6f	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	91bfbc0e-86a3-8ac6-e053-2a95a90af432	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NUCARE PHARMACEUTICALS INC	8d696b8c-eba6-505e-e053-2995a90acb5d	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7f315229-7e8f-67fd-e053-2a91aa0a8cb6	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	67395789-0ac7-2244-e053-2a91aa0a652a	2024-06-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	00327696-c496-4c83-a63e-9e29fd6246d4	2024-04-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Eugia US LLC	1cc94c7a-617c-4238-8248-e3fabc9612c7	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	6a231919-6837-4b09-b66d-3706432b9702	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0050959-c14c-41b6-9a92-fadc5f6feff3	2023-11-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	674ea285-8f84-4603-9655-82200c523fe5	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	d89017aa-b8c3-4fd2-8e68-44e2cfd6f290	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	65f01335-452e-42c6-a59b-4eb03badc55a	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	f8f371c7-09f8-426c-ae22-753cd5626da3	2023-01-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Pharmpak, Inc.	e41b9469-e844-47d9-933a-4c9f4453ecc7	2022-10-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	69ed01b7-a94e-4946-a044-a9f8c37616ec	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-196	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-378	Ondansetron Hydrochloride	Ondansetron Hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current