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 6 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	f08f56de-8678-4da9-8cae-013a5c393453	2024-10-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	2d1b8953-7ff5-4e91-ba97-3ba5c6ea8f71	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	d9321ef6-9fe5-4631-9c58-534fd963cf17	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	146b21e6-f8a5-47eb-b2d9-9ed70d1501d9	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	b297c163-2052-cb22-e053-2995a90a8289	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08	2024-06-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Chartwell RX, LLC	4c74336c-11ec-420a-80e1-d8e4a8f1c46d	2024-06-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	a1dd7420-dd81-2c8e-e053-2995a90ac8e6	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	8f9fc8a2-0cfd-12f1-e053-2995a90acf3d	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	85cd0c27-788d-5fd8-e053-2a91aa0a7c69	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	87fd7e8e-fd04-34ad-e053-2a95a90a236d	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	e8d775b6-478c-499e-82be-bfdf006445e3	2024-04-03	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	a62e2a6a-6235-7580-e053-2a95a90aa2b0	2024-02-26	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	768aa02b-8231-5799-e053-2a91aa0a618d	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	a22a94bc-4fa7-8a4e-e053-2a95a90a6308	2024-01-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	251d7b9a-f935-42f7-b985-91b8bba7637b	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	84234d20-aa73-446f-9a1b-846e0cb80cec	2023-10-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Chartwell RX, LLC	88b7432b-f5a7-40f3-9b0c-e7b125f5103c	2023-10-05	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	f6f2e4ee-dc8b-478d-b0d6-d192119691b7	2023-06-01	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