Application 022524

Type: NDA
Sponsor: MIDATECH PHARMA US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZUPLENZ	ONDANSETRON	FILM;ORAL	4MG	Yes	No
002	ZUPLENZ	ONDANSETRON	FILM;ORAL	8MG	Yes	Yes

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
N022524-001	ZUPLENZ	ONDANSETRON	4MG	FILM / ORAL		RLD	2010-07-02
N022524-002	ZUPLENZ	ONDANSETRON	8MG	FILM / ORAL		RLD	2010-07-02

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022524-001	8580830	2029-11-23	Drug product	2013-12-03
N022524-001	9095577	2030-07-13	Drug product	2015-08-26
N022524-002	8580830	2029-11-23	Drug product	2013-12-03
N022524-002	9095577	2030-07-13	Drug product	2015-08-26

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD, RS	2010-07-02	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`5bbf6a4d5a75…`

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 4 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Hospira, Inc.	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	AvKARE	352de988-d166-c2d8-e063-6294a90acc01	2025-11-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	7949c245-b79f-4eaf-a75f-9a17bd7bd307	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	2025-11-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ondansetron	ONDANSETRON	Accord Healthcare, Inc.	35e0d160-813f-41d7-a382-d2cab6485d9c	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	61758670-91ab-4422-8d9d-e8ca87eecae8	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Lifsa Drugs LLC	c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Amneal Pharmaceuticals LLC	38435346-d505-4bdd-bbc6-a7bcba411033	2025-09-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	9558d296-8edd-4aa1-875a-6247f9a8374d	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	10afd68b-877f-4819-a314-39f2d56d5db9	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da	2025-09-04	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NorthStar Rx LLC	9d5e7650-95be-4b96-b29c-374f673eb7a1	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	ProPharma Distribution	3d5d25eb-8711-ef8c-e063-6394a90a5e03	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Apotex Corp.	2c68d202-fdf7-4b6a-dd7f-82624fcdbd4a	2025-08-26	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Gland Pharma Limited	35716914-ac73-43c0-9aa0-09c99211d941	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Gland Pharma Limited	3efa5604-96c3-42a0-8e99-b3de4a66aa92	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Rising Pharma Holdings, Inc.	eb74425c-c635-4d99-8e98-e63e7359fb89	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NorthStar Rx LLC	281e4296-1d0e-4602-9912-2685ba1640f6	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
89141-444	ZUPLENZ	ondansetron	Midatech Pharma US, Inc.	NDA	Current
89141-444	ZUPLENZ	ondansetron	Midatech Pharma US, Inc.	NDA	Current
89141-444	ZUPLENZ	ondansetron	Fortovia Therapeutics, Inc.	NDA	Current
89141-444	ZUPLENZ	ondansetron	Fortovia Therapeutics, Inc.	NDA	Current
89141-448	ZUPLENZ	ondansetron	Midatech Pharma US, Inc.	NDA	Current
89141-448	ZUPLENZ	ondansetron	Midatech Pharma US, Inc.	NDA	Current
89141-448	ZUPLENZ	ondansetron	Fortovia Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68321	SUPPL	2021-08-09
68302	SUPPL	2021-08-06
7498	SUPPL	2014-09-23
38810	SUPPL	2014-09-22
29828	SUPPL	2013-10-31
17679	SUPPL	2013-10-31
44770	ORIG	2011-05-13
42550	ORIG	2011-05-13
29827	ORIG	2010-07-27
38809	ORIG	2010-07-12