Application 203711

Type: ANDA
Sponsor: QILU

Application Products#

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

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
A203711-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203711-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2014-09-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203711-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2014-09-08	`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	A203711-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203711-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203711-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203711-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203711-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203711-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203711-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203711-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203711-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203711-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203711-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203711-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203711-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203711-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203711-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203711-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203711-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203711-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203711-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203711-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203711-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203711-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203711-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203711-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203711-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203711-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203711-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203711-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203711-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203711-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203711-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203711-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203711-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203711-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203711-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203711-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203711-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203711-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203711-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203711-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	1a44601b-c31c-4779-a688-28cc4cc75e8b	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (product): 0404-9930
ONDANSETRON	ONDANSETRON	Sportpharm LLC	de72f1ec-75dd-4659-a1a0-32b28b72c799	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	A-S Medication Solutions	b60074e5-8e77-4dc0-9244-4205e4adbaef	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (product): 50090-4935
ONDANSETRON	ONDANSETRON	ProPharma Distribution	3d5d25eb-8711-ef8c-e063-6394a90a5e03	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711
ONDANSETRON	ONDANSETRON	Apotex Corp.	2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (product): 60505-6130
ONDANSETRON	ONDANSETRON	Medical Purchasing Solutions, LLC	677b5fc5-9471-638b-e053-2991aa0a7f97	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (product): 71872-7068
ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	5e09e262-dadf-4ae0-825e-448ea8dac174	2022-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203711 application number: ANDA203711 ndc (product): 67184-0507

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9930	ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	ANDA	Current
0404-9930	ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	ANDA	Current
0404-9930	ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	ANDA	Current
50090-4935	ONDANSETRON	ONDANSETRON	A-S Medication Solutions	ANDA	Current
50090-4935	ONDANSETRON	ONDANSETRON	A-S Medication Solutions	ANDA	Current
52584-069	ONDANSETRON	ONDANSETRON	General Injectables and Vaccines, Inc.	ANDA	Current
52584-069	ONDANSETRON	ONDANSETRON	General Injectables and Vaccines, Inc.	ANDA	Current
52584-069	ONDANSETRON	ONDANSETRON	General Injectables and Vaccines, Inc.	ANDA	Current
52584-069	ONDANSETRON	ONDANSETRON	General Injectables and Vaccines, Inc.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
60505-6130	ONDANSETRON	ONDANSETRON	Apotex Corp.	ANDA	Current
67184-0507	ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0507	ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0507	ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0507	ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
70518-2650	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-2650	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-2650	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
71872-7068	ONDANSETRON	ONDANSETRON	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7068	ONDANSETRON	ONDANSETRON	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40323	ORIG	2014-09-23
32462	ORIG	2014-09-10