Application 079224

Type: ANDA
Sponsor: GLAND PHARMA LTD

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	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
A079224-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079224-001	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	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`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	A079224-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079224-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b746d4db-43e6-4219-9e6b-f53e59581305	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 23155-547
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 72266-123
Ondansetron	ONDANSETRON	Gland Pharma Limited	3efa5604-96c3-42a0-8e99-b3de4a66aa92	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 68083-113
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 25021-777
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 23155-548

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-547	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals Inc	ANDA	Current
23155-547	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-547	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-547	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-548	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals Inc	ANDA	Current
23155-548	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-548	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-548	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
25021-777	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-777	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-777	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-777	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-777	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
50090-2342	ONDANSETRON	ONDANSETRON	A-S Medication Solutions	ANDA	Current
67457-440	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-440	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-440	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-440	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-440	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
68071-4191	ONDANSETRON	ONDANSETRON	NuCare Pharmaceuticals,Inc.	ANDA	Current
68083-113	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-113	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-113	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-113	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
70518-1422	Ondansetron	ondansetron hydrochloride	REMEDYREPACK INC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-776	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71872-7069	Ondansetron	ondansetron hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7069	Ondansetron	ondansetron hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7138	Ondansetron Hydrochloride	Ondansetron	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7138	Ondansetron Hydrochloride	Ondansetron	Medical Purchasing Solutions, LLC	ANDA	Current
72266-123	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-123	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-123	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-123	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current