Application 020605

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	SOLUTION;ORAL	EQ 4MG BASE/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020605-001	ZOFRAN	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1997-01-24

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020605-001	ZOFRAN	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1997-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1997-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020605-001	ZOFRAN	EQ 4MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1997-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL		RLD	1997-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020605-001	ZOFRAN	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RLD, RS	1997-01-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020605-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020605-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020605-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020605-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020605-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020605-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020605-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020605-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020605-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020605-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020605-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020605-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020605-001	AA	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020605-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020605-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020605-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020605-001	AA	1	`cb3db0bc1861…`

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57b0a1e5-5dfa-64a0-e063-6394a90acf36	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Ascend Laboratories, LLC	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ondansetron	ONDANSETRON HYDROCHLORIDE	Cardinal Health 107, LLC	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	3f2e8efe-7fd4-407c-a77b-bd6dd04608e2	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	ee3e8cbe-4f0b-4361-a1b5-8329d85a2932	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	561dce26-92fa-e00b-e063-6294a90a1ab2	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	0a14eb9a-0385-40e9-a7ec-71435450ac91	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Unit Dose Solutions, Inc.	5566aebb-d84d-6d6a-e063-6294a90a746f	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	58f16a00-3e66-29de-e053-2991aa0a59a0	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	American Health Packaging	9f015e60-1aec-4ae7-b28f-42f6c8f50455	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Coupler LLC	546191d2-d092-6342-e063-6294a90a0cd3	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	00b17a8e-9d38-a8d4-e063-6294a90a153e	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Redpharm Drug	541b9a0d-ae94-db6f-e063-6394a90a9805	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	c0be25a0-e13d-4242-93dc-0b86e82aadd7	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	5cc67d95-6629-4451-9e34-2f7a60482be5	2026-04-10	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	b1324076-f83e-4816-9e02-6b2a689010bc	2026-04-05	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	e2c0e86c-e7fc-48f9-a894-02da8761001c	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	A-S Medication Solutions	e0f69f57-aeb9-4890-85aa-e5976208e8be	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	Cardinal Health 107, LLC	30107d6f-5128-484f-b713-65244a98dc67	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	7e862601-1d8a-455b-8ce5-1a32478b309f	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0489	ZOFRAN	ondansetron hydrochloride	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82463	SUPPL	2025-06-04
82442	SUPPL	2025-06-03
69072	SUPPL	2021-10-22
69055	SUPPL	2021-10-21
67246	SUPPL	2021-04-29
67241	SUPPL	2021-04-29
49977	SUPPL	2017-10-06
49963	SUPPL	2017-10-06
45879	SUPPL	2016-11-10
45876	SUPPL	2016-11-10
45485	SUPPL	2016-09-30
2863	SUPPL	2014-09-23
34949	SUPPL	2014-09-22
25309	SUPPL	2013-12-13
12836	SUPPL	2013-12-11
44061	ORIG	2011-12-20
25308	SUPPL	2011-09-16
12835	SUPPL	2011-09-16
12834	SUPPL	2010-09-29
2862	SUPPL	2010-09-27
41477	SUPPL	2009-09-16
20761	SUPPL	2007-09-26
25307	SUPPL	2006-09-18
12833	SUPPL	2006-08-23
25306	SUPPL	2006-01-06
12832	SUPPL	2006-01-05
12831	SUPPL	2004-12-03
2861	SUPPL	2004-12-02
12830	SUPPL	2000-12-13
2860	SUPPL	2000-12-13
41476	ORIG	1997-01-24