Application 077717

Type: ANDA
Sponsor: NESHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	No	No
002	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	8MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077717-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL			2007-06-25
A077717-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL			2007-06-25

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077717-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077717-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	2007-06-25	`74a2ff9319b5…`

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 7 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	85cd0c27-788d-5fd8-e053-2a91aa0a7c69	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	87fd7e8e-fd04-34ad-e053-2a95a90a236d	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	e8d775b6-478c-499e-82be-bfdf006445e3	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	a62e2a6a-6235-7580-e053-2a95a90aa2b0	2024-02-26	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	768aa02b-8231-5799-e053-2a91aa0a618d	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	a22a94bc-4fa7-8a4e-e053-2a95a90a6308	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON HYDROCHLORIDE	Eugia US LLC	1cc94c7a-617c-4238-8248-e3fabc9612c7	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	6a231919-6837-4b09-b66d-3706432b9702	2023-11-20	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0050959-c14c-41b6-9a92-fadc5f6feff3	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON	A-S Medication Solutions	251d7b9a-f935-42f7-b985-91b8bba7637b	2023-10-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	84234d20-aa73-446f-9a1b-846e0cb80cec	2023-10-16	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Chartwell RX, LLC	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	2023-10-05	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	d89017aa-b8c3-4fd2-8e68-44e2cfd6f290	2023-08-16	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	f6f2e4ee-dc8b-478d-b0d6-d192119691b7	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Medical Purchasing Solutions, LLC	79756604-56e6-d0ef-e053-2991aa0adc99	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Medical Purchasing Solutions, LLC	70bf93bc-e979-f080-e053-2991aa0a21df	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Medical Purchasing Solutions, LLC	89698ef8-62d3-77e4-e053-2995a90ab9db	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	ad92ffb6-dc63-48dc-9fcc-37fd3d42a75c	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Medical Purchasing Solutions, LLC	677b5fc5-9471-638b-e053-2991aa0a7f97	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON

Reported adverse events (FAERS/openFDA)#

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