Application 020103

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	Yes	No
002	ZOFRAN	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 8MG BASE	Yes	No
003	ZOFRAN	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 24MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020103-001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31
N020103-002	ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31
N020103-003	ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27

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 4 · 129 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	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020103-002	ZOFRAN	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020103-003	ZOFRAN	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020103-001	ZOFRAN	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-12-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020103-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020103-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020103-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020103-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020103-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020103-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020103-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020103-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020103-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020103-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020103-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020103-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020103-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020103-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020103-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020103-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020103-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020103-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020103-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020103-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020103-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020103-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020103-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020103-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020103-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020103-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020103-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020103-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020103-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020103-003	AB	1	`ea99ee380514…`

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 4 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	Bryant Ranch Prepack	3aeb533a-e72c-4af8-9867-b71d2eba9a49	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	115e8fb5-61f5-4719-8eb3-063b7ca194ae	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	d6694136-7591-4f23-8415-f2aa3c8bab40	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b406d22-f1bf-460d-e063-6294a90a6b6f	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	91bfbc0e-86a3-8ac6-e053-2a95a90af432	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NUCARE PHARMACEUTICALS INC	8d696b8c-eba6-505e-e053-2995a90acb5d	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7f315229-7e8f-67fd-e053-2a91aa0a8cb6	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmceuticals,Inc.	67395789-0ac7-2244-e053-2a91aa0a652a	2024-06-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	00327696-c496-4c83-a63e-9e29fd6246d4	2024-04-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Eugia US LLC	1cc94c7a-617c-4238-8248-e3fabc9612c7	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	6a231919-6837-4b09-b66d-3706432b9702	2023-11-20	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	e0050959-c14c-41b6-9a92-fadc5f6feff3	2023-11-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	674ea285-8f84-4603-9655-82200c523fe5	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Fresenius Kabi USA, LLC	d89017aa-b8c3-4fd2-8e68-44e2cfd6f290	2023-08-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	65f01335-452e-42c6-a59b-4eb03badc55a	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	f8f371c7-09f8-426c-ae22-753cd5626da3	2023-01-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Pharmpak, Inc.	e41b9469-e844-47d9-933a-4c9f4453ecc7	2022-10-09	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	69ed01b7-a94e-4946-a044-a9f8c37616ec	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4	2022-04-01	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0675	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0676	ZOFRAN	ondansetron hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0173-0447	ZOFRAN	ondansetron hydrochloride	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82462	SUPPL	2025-06-04
82441	SUPPL	2025-06-03
69071	SUPPL	2021-10-22
69054	SUPPL	2021-10-21
67244	SUPPL	2021-04-29
67240	SUPPL	2021-04-29
49976	SUPPL	2017-10-06
49962	SUPPL	2017-10-06
45878	SUPPL	2016-11-10
45875	SUPPL	2016-11-10
45484	SUPPL	2016-09-30
21165	SUPPL	2014-09-23
12219	SUPPL	2014-09-22
2023	SUPPL	2013-12-13
34267	SUPPL	2013-12-11
23566	ORIG	2011-12-20
21164	SUPPL	2011-09-16
12218	SUPPL	2011-09-16
12217	SUPPL	2010-09-29
2022	SUPPL	2010-09-27
41145	SUPPL	2009-09-16
20474	SUPPL	2009-09-16
20473	SUPPL	2007-09-14
21163	SUPPL	2006-09-18
12216	SUPPL	2006-08-23
21162	SUPPL	2006-01-06
34266	SUPPL	2006-01-05
34263	SUPPL	2006-01-05
34265	SUPPL	2005-02-23
21161	SUPPL	2005-02-23
34264	SUPPL	2004-12-03
2021	SUPPL	2004-12-02
21160	SUPPL	2004-07-01
2020	SUPPL	2004-07-01
12215	SUPPL	2000-12-13
2019	SUPPL	2000-12-13
41144	SUPPL	1999-08-27
20472	SUPPL	1999-08-27