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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD, RS	2010-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD, RS	2010-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD, RS	2010-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022524-001	ZUPLENZ	4MG	FILM / ORAL	RLD	2010-07-02	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022524-002	ZUPLENZ	8MG	FILM / ORAL	RLD	2010-07-02	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022524-001	8580830	2029-11-23	Drug product	2013-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022524-001	9095577	2030-07-13	Drug product	2015-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022524-002	8580830	2029-11-23	Drug product	2013-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022524-002	9095577	2030-07-13	Drug product	2015-08-26	`c2088c7a36db…`
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…`

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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	416be720-82e8-4a6d-8531-c1a29869daae	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	f175a336-433b-7ab2-e053-2995a90ad5ca	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	c0d827d0-333f-4187-ac75-9dc7d34b6169	2026-08-11	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	66ac9c17-bea7-4f8d-8a27-a1e0f9e65945	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	7975d78c-9bb6-467a-9c2d-ea15bde7af5c	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	70b48280-ef74-472b-abc3-128962bfcb05	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	3c4cda2f-13d9-42c5-b449-77deb06c8de5	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	5a81a39b-051b-414e-a6b0-d844de4e9ab4	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	02ddd5f5-76d3-4f1c-9af3-d39e05a19c29	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	41366a20-0727-0446-e063-6294a90a957f	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	1a44601b-c31c-4779-a688-28cc4cc75e8b	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	HAWAII REPACK, INC.	b76c5cc9-f1ca-428b-8989-36a66802b650	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	18063a64-a4c0-4bad-911b-00df5c7bb65d	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	9c3ad9c1-474e-4331-a017-09cec46702d8	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	77397df5-5a4f-41b2-98bc-f817a1e497fc	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Sportpharm LLC	de72f1ec-75dd-4659-a1a0-32b28b72c799	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	822404ad-af08-4c62-ae38-7d9819e86079	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	3207cf04-73b7-24ce-e054-00144ff8d46c	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc	4575d288-be0c-f6c3-e063-6294a90af708	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	1b9c2d9f-62a8-4d26-a041-a598bc59e300	2026-06-26	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