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HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-01-04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FREE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1993-12-10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N020007-001	ZOFRAN	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1991-01-04	`84e616aacf4f…`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N020007-003	ZOFRAN PRESERVATIVE FREE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1993-12-10	`84e616aacf4f…`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 5 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	Dr. Reddy's Laboratories Limited	476e704c-95ae-4591-94f7-ee4ab827ff13	2021-05-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	bde7c22c-0047-4735-8df6-b48e8dfa478a	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	08db5ce7-4dcf-4581-a0bf-f405cc22b48d	2018-08-27	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