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 5 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	ee668456-a214-4452-ab9d-ec00eaa41d79	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Aurobindo Pharma Limited	cab63f24-8728-4927-aba5-53e8d2e44cdb	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	72f29916-0f95-102d-e053-2991aa0aa5cd	2025-06-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	ee1f115f-c8f8-4526-b827-c8e48aeb5050	2025-06-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40d9cc46-aced-4866-812b-7d82933596ae	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0b9ee-c1d2-7818-e053-2995a90a3e96	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	2eeb3c61-4ce9-d8ed-e063-6294a90a00d3	2025-02-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Asclemed USA, Inc.	e436e361-da0f-7d6d-e053-2995a90a10e4	2025-02-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	7b062fa9-e004-23d5-e053-2a91aa0a20cd	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	99ac0a5e-dd2a-4352-e053-2a95a90a68fd	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron ODT	ONDANSETRON	Advanced Rx of Tennessee, LLC	af836a30-5e51-5c97-e053-2995a90a15b9	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0ea2c-0788-4e8a-e053-2a95a90a2f32	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0cd50-aa4f-55bc-e053-2995a90a2d3a	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	e183c59c-2a7c-dba3-e053-2a95a90acf87	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx of Tennessee, LLC	2a8603a9-5b6f-b921-e063-6394a90ae29c	2024-12-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx of Tennessee, LLC	2a863485-a0a8-db63-e063-6294a90ab605	2024-12-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	2553816f-161e-ac86-e063-6394a90aad6d	2024-10-25	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