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 8 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Proficient Rx LP	bd09b19b-3b7b-474a-9c88-98b813d2c53b	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	47e26779-9465-410c-96b3-091119ae62f2	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	HF Acquisition Co LLC, DBA HealthFirst	993cd1d7-70a1-a431-e053-2a95a90a5771	2022-12-10	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	PharmPak, Inc.	8e289184-6046-4b55-97d2-cb276d5782d5	2022-10-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Proficient Rx LP	4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Qilu Pharmaceutical Co., Ltd.	5e09e262-dadf-4ae0-825e-448ea8dac174	2022-03-02	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON TABLETS	Natco Pharma Limited	59c817b7-a1c6-48a5-9bfc-2c381532bfd9	2021-11-29	Warnings, Adverse reactions	Name fallback brand name: Ondansetron
ondansetron	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	bde7c22c-0047-4735-8df6-b48e8dfa478a	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: ondansetron
ONDANSETRON	ONDANSETRON	Proficient Rx LP	9913ed0c-aaad-45e1-b522-98ad170c2e8a	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	Proficient Rx LP	f1191e52-982e-49d1-946e-01b469ccedfe	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Proficient Rx LP	41c0dc3d-a616-425e-9073-625a0cb692c4	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
ONDANSETRON	ONDANSETRON	Sun Pharmaceutical Industries, Inc.	834bc56a-657d-4733-9a60-47040cb5c7bf	2019-09-11	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON generic name: ONDANSETRON
Ondansetron	ONDANSETRON	West-Ward Pharmaceuticals Corp	bb4bc810-db26-471b-9ce7-6e2fb3018af0	2018-12-14	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