Application 020007

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ZOFRAN PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N020007-001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-01-04
N020007-003	ZOFRAN PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1993-12-10

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	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020007-001	ZOFRAN	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RLD	1991-01-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RLD	1993-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020007-001	ZOFRAN	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RLD	1991-01-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RLD	1993-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`74a2ff9319b5…`

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 3 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	36d64400-2d13-4a1a-a1ca-4741cd3d3f1a	2025-09-03	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Rising Pharma Holdings, Inc.	90e0e508-75f7-4c8b-bb38-898aa4c531c3	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	426ba54f-199a-41d1-8c27-f827bea56854	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	NorthStar Rx LLC	ac3dfb81-a4c7-4147-9374-c234153b7c51	2025-08-11	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PHOENIX RX LLC	3a76bae2-04c2-ee2d-e063-6394a90ad4c8	2025-07-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	57578387-1918-4e56-a564-f14fb22340bf	2025-07-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	cf10d256-dd89-4a91-a3ed-81db505a79c2	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	Baxter Healthcare Corporation	729d865f-d84a-495e-9456-4bceebb6e03f	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1a0c4dc6-643e-4ee7-92a9-edb98049a5ba	2025-06-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Precision Dose Inc.	04800a86-2391-44e6-8763-d65e8a916c26	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f8ada0e4-5c1b-17ab-e053-6294a90a12b8	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Asclemed USA, Inc.	65b0b2e2-37fd-4d08-9674-954d62bb531a	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b43e15d6-b778-7575-e053-2995a90a93a0	2025-01-14	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	AvPAK	e4766235-ac44-ca93-78a6-66d4ded33ada	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products, LLC	2e0b1b09-9e68-4728-82d5-1f86510a0f2a	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products LLC	54e8981e-6880-4d4f-bc46-600c2af59698	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products LLC	89091629-d15e-4e95-aed8-8bc983c78302	2024-12-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	8585e68b-965f-4f95-a5df-eea023cd5f82	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82461	SUPPL	2025-06-04
82440	SUPPL	2025-06-03
69070	SUPPL	2021-10-22
69057	SUPPL	2021-10-21
67243	SUPPL	2021-04-29
67239	SUPPL	2021-04-29
62272	SUPPL	2020-03-24
47546	SUPPL	2017-03-14
47512	SUPPL	2017-03-09
19930	SUPPL	2014-09-23
12130	SUPPL	2014-09-22
19929	SUPPL	2013-12-13
34178	SUPPL	2013-12-11
1898	SUPPL	2012-11-16
12129	SUPPL	2012-11-15
23967	ORIG	2011-12-20
12128	SUPPL	2011-09-16
1897	SUPPL	2011-09-16
19928	SUPPL	2011-07-13
12127	SUPPL	2010-09-29
1896	SUPPL	2010-09-28
20446	SUPPL	2009-09-16
41117	SUPPL	2009-01-12
23968	ORIG	2007-07-09
19927	SUPPL	2006-09-18
34177	SUPPL	2006-08-23
12126	SUPPL	2006-01-05
12125	SUPPL	2005-03-30
1895	SUPPL	2005-03-30
12124	SUPPL	2004-12-03
19926	SUPPL	2004-12-02
20445	SUPPL	1997-10-31
53117	SUPPL	1900-01-01
52921	SUPPL	1900-01-01
52920	SUPPL	1900-01-01
52919	SUPPL	1900-01-01
52918	SUPPL	1900-01-01
52917	SUPPL	1900-01-01