Application 078602

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	No	No
002	ONDANSETRON	ONDANSETRON	TABLET, ORALLY DISINTEGRATING;ORAL	8MG	No	No

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
A078602-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL			2011-02-24
A078602-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL			2011-02-24

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2011-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078602-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078602-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2011-02-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

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	A078602-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078602-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078602-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078602-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078602-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078602-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078602-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078602-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078602-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078602-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078602-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078602-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078602-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078602-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078602-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078602-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078602-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078602-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078602-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078602-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078602-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078602-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078602-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078602-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078602-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078602-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A078602-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078602-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078602-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078602-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078602-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078602-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078602-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078602-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078602-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078602-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078602-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A078602-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078602-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078602-002	AB	1	`3bdfa0b2c4d7…`

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 8 · 152 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	b50c1767-8a50-49ab-be31-6533021ae7c4	2025-08-21	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON HYDROCHLORIDE	NorthStar Rx LLC	ac3dfb81-a4c7-4147-9374-c234153b7c51	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON	Gland Pharma Limited	35716914-ac73-43c0-9aa0-09c99211d941	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Gland Pharma Limited	3efa5604-96c3-42a0-8e99-b3de4a66aa92	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Rising Pharma Holdings, Inc.	eb74425c-c635-4d99-8e98-e63e7359fb89	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NorthStar Rx LLC	281e4296-1d0e-4602-9912-2685ba1640f6	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	ee668456-a214-4452-ab9d-ec00eaa41d79	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	cf10d256-dd89-4a91-a3ed-81db505a79c2	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON	Aurobindo Pharma Limited	cab63f24-8728-4927-aba5-53e8d2e44cdb	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc.	72f29916-0f95-102d-e053-2991aa0aa5cd	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	ee1f115f-c8f8-4526-b827-c8e48aeb5050	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	40d9cc46-aced-4866-812b-7d82933596ae	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Bryant Ranch Prepack	384a5cfb-05dd-2b79-73f4-a01a47a9eb3e	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Advanced Rx Pharmacy of Tennessee, LLC	f1a0b9ee-c1d2-7818-e053-2995a90a3e96	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	ATLANTIC BIOLOGICALS CORP.	e5ab38a2-5921-4320-a313-e0080c078046	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals, Inc.	2eeb3c61-4ce9-d8ed-e063-6294a90a00d3	2025-02-24	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Asclemed USA, Inc.	e436e361-da0f-7d6d-e053-2995a90a10e4	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	7b062fa9-e004-23d5-e053-2a91aa0a20cd	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-346	ONDANSETRON	ONDANSETRON	Rnabaxy Pharmaceuticals Inc.	ANDA	Current
63304-347	ONDANSETRON	ONDANSETRON	Rnabaxy Pharmaceuticals Inc.	ANDA	Current