Application 091483

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	SOLUTION;ORAL	EQ 4MG BASE/5ML	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
A091483-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091483-001	AA

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	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091483-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-31	`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	A091483-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091483-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091483-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091483-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091483-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091483-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091483-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091483-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091483-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091483-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091483-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091483-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091483-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091483-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091483-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091483-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091483-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091483-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091483-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091483-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091483-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091483-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091483-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091483-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091483-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091483-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091483-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091483-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091483-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091483-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091483-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091483-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091483-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091483-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091483-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091483-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091483-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091483-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091483-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091483-001	AA	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	American Health Packaging	92b96072-e8f2-4fd6-aaa0-b73fed214319	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483 ndc (product): 60687-252
Ondansetron	ONDANSETRON	AvPAK	05cf8d4f-ac57-4177-e063-6394a90ae804	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483
Ondansetron	ONDANSETRON	Amneal Pharmaceuticals LLC	38435346-d505-4bdd-bbc6-a7bcba411033	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483 ndc (product): 65162-691
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091483 application number: ANDA091483 ndc (product): 17856-0691

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7073	Ondansetron	Ondansetron	Major Pharmaceuticals	ANDA	Current
0904-7073	Ondansetron	Ondansetron	Major Pharmaceuticals	ANDA	Current
0904-7073	Ondansetron	Ondansetron	Major Pharmaceuticals	ANDA	Current
17856-0691	Ondansetron	Ondansetron	Atlantic Biologicals Corps	ANDA	Current
17856-0691	Ondansetron	Ondansetron	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0691	Ondansetron	Ondansetron	Atlantic Biologicals Corps	ANDA	Current
17856-0691	Ondansetron	Ondansetron	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-4091	Ondansetron	Ondansetron	Atlantic Biologicals Corps	ANDA	Current
60687-252	Ondansetron	Ondansetron	American Health Packaging	ANDA	Current
60687-252	Ondansetron	Ondansetron	American Health Packaging	ANDA	Current
60687-252	Ondansetron	Ondansetron	American Health Packaging	ANDA	Current
60687-252	Ondansetron	Ondansetron	American Health Packaging	ANDA	Current
65162-691	Ondansetron	Ondansetron	Amneal Pharmaceuticals LLC	ANDA	Current
65162-691	Ondansetron	Ondansetron	Amneal Pharmaceuticals LLC	ANDA	Current
65162-691	Ondansetron	Ondansetron	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
65162-691	Ondansetron	Ondansetron	Amneal Pharmaceuticals LLC	ANDA	Current
65162-691	Ondansetron	Ondansetron	Amneal Pharmaceuticals LLC	ANDA	Current
70166-486	Ondansetron	Ondansetron	Lohxa	ANDA	Current
70166-486	Ondansetron	Ondansetron	Lohxa	ANDA	Current