Application 090648

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
A090648-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090648-001	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	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2012-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2012-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2012-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2012-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090648-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2012-06-15	`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	A090648-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090648-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090648-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090648-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090648-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090648-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090648-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090648-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090648-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090648-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090648-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090648-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090648-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090648-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090648-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090648-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090648-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090648-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090648-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090648-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090648-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090648-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090648-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090648-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090648-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090648-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090648-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090648-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090648-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090648-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090648-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090648-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090648-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090648-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090648-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090648-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090648-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090648-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090648-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090648-001	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	JVET PHARMACEUTICALS LLC	95ca0d81-a0a8-441d-820e-cb6624018a15	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090648 application number: ANDA090648
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): 090648 application number: ANDA090648 ndc (product): 23155-549
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090648 application number: ANDA090648 ndc (product): 72266-124
Ondansetron	ONDANSETRON	Gland Pharma Limited	35716914-ac73-43c0-9aa0-09c99211d941	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090648 application number: ANDA090648 ndc (product): 68083-114
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): 090648 application number: ANDA090648 ndc (product): 23155-550

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-549	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals Inc	ANDA	Current
23155-549	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-549	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-549	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-550	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals Inc	ANDA	Current
23155-550	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-550	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals	ANDA	Current
23155-550	ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
25021-782	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-782	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-782	ondansetron	ondansetron hydrochloride	Sagent Pharmaceuticals	ANDA	Current
67457-441	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-441	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-441	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
67457-441	Ondansetron Hydrochloride	Ondansetron	Mylan Institutional LLC	ANDA	Current
68083-114	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-114	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-114	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
68083-114	Ondansetron	Ondansetron	Gland Pharma Limited	ANDA	Current
70518-2895	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70518-2895	ONDANSETRON	ONDANSETRON	REMEDYREPACK INC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-777	Ondansetron	ondansetron hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
72266-124	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-124	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-124	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current
72266-124	Ondansetron	Ondansetron	Fosun Pharma USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22713	ORIG	2013-01-22