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 3 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	JVET PHARMACEUTICALS LLC	95ca0d81-a0a8-441d-820e-cb6624018a15	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	36592150-7e19-474c-9f96-cc8341e28b5d	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Direct Rx	b38feff2-900a-4e0c-8260-8f090edbc0bc	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	df736abd-9cec-4e90-e053-2995a90aab5e	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	50383ef5-6e6e-63a7-e054-00144ff88e88	2026-03-04	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	ef6ce203-4ae3-19c9-e053-2995a90af796	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Direct_Rx	90b73778-2ab5-5460-e053-2a95a90abbc1	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	378d0963-d026-4478-8202-fbb636904a37	2026-02-18	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b746d4db-43e6-4219-9e6b-f53e59581305	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	9dff6676-e69e-779d-e053-2995a90a7c81	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Golden State Medical Supply, Inc.	2b9ea1fc-59a4-8189-e063-6394a90a9ae6	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	76666e7e-3312-6f9d-e053-2991aa0af705	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	15d0a711-ef3b-4d93-8fbc-17a45f96af8a	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	d117de5f-64e5-464c-b782-de0f07e66c8e	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ondansetron	ONDANSETRON	Cardinal Health 107, LLC	26aff90c-49ea-46ac-bbf3-c188c2b061c9	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	AvPAK	05cf8d4f-ac57-4177-e063-6394a90ae804	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Glenmark Pharmaceuticals Inc., USA	eee5217a-eba8-463a-812d-bf3c66f0934f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f2b502e2-03ed-fe5c-e053-2995a90a368e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	db9a0d22-9339-4319-e053-2a95a90a9592	2026-01-01	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.