Application 078139

Type: ANDA
Sponsor: MYLAN

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 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
A078139-001	ONDANSETRON	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL			2007-06-25
A078139-002	ONDANSETRON	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL			2007-06-25

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL		2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078139-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078139-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078139-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078139-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078139-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078139-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078139-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078139-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078139-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078139-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078139-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078139-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078139-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078139-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078139-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078139-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078139-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078139-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078139-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078139-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078139-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078139-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078139-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078139-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078139-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078139-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078139-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078139-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078139-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078139-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078139-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078139-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078139-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078139-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078139-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078139-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078139-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078139-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078139-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078139-002	AB	1	`9b2671bbb829…`

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 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	e07c38c0-e1c2-01de-e053-2995a90a390a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Northwind Health Company, LLC	f29f5cfa-3cc4-7d53-e053-2995a90ae844	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Redpharm Drug	300b1916-a3d8-0220-e063-6394a90a6f55	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Ipca Laboratories Limited	8e24f935-87fe-4b6a-b265-60b1039f38d5	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Natco Pharma USA LLC	64527de5-0b92-4340-9243-7a37e8ff96d9	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Hospira, Inc.	e0862c02-781f-4b10-ae50-9c9c4ca26f6d	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	AvKARE	352de988-d166-c2d8-e063-6294a90acc01	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	7949c245-b79f-4eaf-a75f-9a17bd7bd307	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ondansetron	ONDANSETRON	Accord Healthcare, Inc.	35e0d160-813f-41d7-a382-d2cab6485d9c	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON HYDROCHLORIDE	Atlantic Biologics Corp.	41d71d26-0d42-b368-e063-6394a90add43	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	61758670-91ab-4422-8d9d-e8ca87eecae8	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Lifsa Drugs LLC	c66d63cf-a0e5-4cb5-bdf8-9d1115cba23e	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Amneal Pharmaceuticals LLC	38435346-d505-4bdd-bbc6-a7bcba411033	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	9558d296-8edd-4aa1-875a-6247f9a8374d	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PD-Rx Pharmaceuticals, Inc.	10afd68b-877f-4819-a314-39f2d56d5db9	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals, Inc.	b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NorthStar Rx LLC	9d5e7650-95be-4b96-b29c-374f673eb7a1	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	ProPharma Distribution	3d5d25eb-8711-ef8c-e063-6394a90a5e03	2025-08-27	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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7732	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7732	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7732	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7732	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7732	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7734	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7734	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7734	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7734	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7734	Ondansetron	Ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
11819-365	Ondansetron	Ondansetron	HHS/Program Support Center/Supply Service Center	ANDA	Current
11819-371	Ondansetron	Ondansetron	United States Department of Health & Human Services	ANDA	Current
11819-371	Ondansetron	Ondansetron	United States Department of Health & Human Services	ANDA	Current
35356-678	Ondansetron	Ondansetron	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
70518-1198	Ondansetron	Ondansetron	REMEDYREPACK INC.	ANDA	Current
70518-1198	Ondansetron	Ondansetron	REMEDYREPACK INC.	ANDA	Current