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 2 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Sportpharm LLC	de72f1ec-75dd-4659-a1a0-32b28b72c799	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	822404ad-af08-4c62-ae38-7d9819e86079	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	3207cf04-73b7-24ce-e054-00144ff8d46c	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc	4575d288-be0c-f6c3-e063-6294a90af708	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	1b9c2d9f-62a8-4d26-a041-a598bc59e300	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	3c34ca82-9705-4784-be7c-8b50351d14fc	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	e87a5803-e872-43f7-8a15-79aa236e8c07	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	BluePoint Laboratories	ed1132ec-c2cd-4646-b69d-26663bb937a4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	American Health Packaging	92b96072-e8f2-4fd6-aaa0-b73fed214319	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hospira, Inc.	d62cd60b-f87e-4825-bead-1d18bbc4e480	2026-05-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hospira, Inc.	6a11f61b-2318-4382-2b91-4366e4bb53fa	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	A-S Medication Solutions	b60074e5-8e77-4dc0-9244-4205e4adbaef	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	c83821ad-822e-47dc-8108-612312cf3a16	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Civica, Inc.	70437694-0341-4f3b-824c-06843403443f	2026-04-19	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	97713356-f42b-4a67-95f6-561afa68c0c2	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40258e4b-5e67-46c0-8ef0-3e8bfe36ba11	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	98c1413c-ff7f-4554-9e9f-289038b39ca6	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	c29ca6df-621d-44b6-98fc-b48666573366	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	5bacb621-1261-25d9-e053-2991aa0afa3b	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PAI Holdings, LLC dba PAI Pharma	68a4d845-0c1c-4867-bfca-c0fb11dc93cd	2026-03-31	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.