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 2 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	3c34ca82-9705-4784-be7c-8b50351d14fc	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	e87a5803-e872-43f7-8a15-79aa236e8c07	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	BluePoint Laboratories	ed1132ec-c2cd-4646-b69d-26663bb937a4	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	American Health Packaging	92b96072-e8f2-4fd6-aaa0-b73fed214319	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hospira, Inc.	d62cd60b-f87e-4825-bead-1d18bbc4e480	2026-05-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hospira, Inc.	6a11f61b-2318-4382-2b91-4366e4bb53fa	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	A-S Medication Solutions	b60074e5-8e77-4dc0-9244-4205e4adbaef	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	c83821ad-822e-47dc-8108-612312cf3a16	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Civica, Inc.	70437694-0341-4f3b-824c-06843403443f	2026-04-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	97713356-f42b-4a67-95f6-561afa68c0c2	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40258e4b-5e67-46c0-8ef0-3e8bfe36ba11	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	98c1413c-ff7f-4554-9e9f-289038b39ca6	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	c29ca6df-621d-44b6-98fc-b48666573366	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	5bacb621-1261-25d9-e053-2991aa0afa3b	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PAI Holdings, LLC dba PAI Pharma	68a4d845-0c1c-4867-bfca-c0fb11dc93cd	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	JVET PHARMACEUTICALS LLC	95ca0d81-a0a8-441d-820e-cb6624018a15	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	36592150-7e19-474c-9f96-cc8341e28b5d	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Direct Rx	b38feff2-900a-4e0c-8260-8f090edbc0bc	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	df736abd-9cec-4e90-e053-2995a90aab5e	2026-03-13	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