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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078139-001	ONDANSETRON	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078139-002	ONDANSETRON	8MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2007-06-25	`782e0a99824c…`

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 1 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Sportpharm LLC	3c4cda2f-13d9-42c5-b449-77deb06c8de5	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	5a81a39b-051b-414e-a6b0-d844de4e9ab4	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	A-S Medication Solutions	02ddd5f5-76d3-4f1c-9af3-d39e05a19c29	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	41366a20-0727-0446-e063-6294a90a957f	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Henry Schein, Inc.	1a44601b-c31c-4779-a688-28cc4cc75e8b	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ondansetron	ONDANSETRON HYDROCHLORIDE	Ascend Laboratories, LLC	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: ondansetron
ondansetron	ONDANSETRON HYDROCHLORIDE	Cardinal Health 107, LLC	cb02f2d7-31a9-4f12-880e-7ce7d85440d4	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: ondansetron
Ondansetron	ONDANSETRON	HAWAII REPACK, INC.	b76c5cc9-f1ca-428b-8989-36a66802b650	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	18063a64-a4c0-4bad-911b-00df5c7bb65d	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	9c3ad9c1-474e-4331-a017-09cec46702d8	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	77397df5-5a4f-41b2-98bc-f817a1e497fc	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Sportpharm LLC	de72f1ec-75dd-4659-a1a0-32b28b72c799	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Sportpharm LLC	822404ad-af08-4c62-ae38-7d9819e86079	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	St. Mary's Medical Park Pharmacy	3207cf04-73b7-24ce-e054-00144ff8d46c	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	NuCare Pharmaceuticals,Inc	4575d288-be0c-f6c3-e063-6294a90af708	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	1b9c2d9f-62a8-4d26-a041-a598bc59e300	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Cardinal Health 107, LLC	3c34ca82-9705-4784-be7c-8b50351d14fc	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Preferred Pharmaceuticals Inc.	e87a5803-e872-43f7-8a15-79aa236e8c07	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	BluePoint Laboratories	ed1132ec-c2cd-4646-b69d-26663bb937a4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	American Health Packaging	92b96072-e8f2-4fd6-aaa0-b73fed214319	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON

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