Application 076930

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 4MG BASE	No	No
002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 8MG BASE	No	No
003	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET; ORAL	EQ 16MG	No	No
004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 24MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076930-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25
A076930-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25
A076930-004	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / 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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076930-004	ONDANSETRON HYDROCHLORIDE	EQ 24MG BASE	TABLET / ORAL	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076930-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	2007-06-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076930-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076930-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076930-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076930-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076930-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076930-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076930-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076930-002	AB	1	`ea99ee380514…`

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 2 of 5 · 83 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	REMEDYREPACK INC.	5cc67d95-6629-4451-9e34-2f7a60482be5	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Sportpharm LLC	b1324076-f83e-4816-9e02-6b2a689010bc	2026-04-05	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	e2c0e86c-e7fc-48f9-a894-02da8761001c	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride 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 brand name: Ondansetron Hydrochloride 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 brand name: ONDANSETRON HYDROCHLORIDE 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 brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Chartwell RX, LLC.	2086bae8-7c3c-4663-93ac-c86407c524c2	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f76d27c5-acd4-482c-e053-6294a90a5284	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	f29f8ae1-4826-d8eb-e053-2a95a90a691a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	852a3251-bf28-5557-e053-2991aa0a4fbd	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Northwind Health Company, LLC	db99c77a-0b01-9da6-e053-2a95a90a5199	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	QPharma, Inc.	fbe71308-2927-2467-e053-6394a90aa419	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	QPharma, Inc.	2fa30bdb-f60e-40a7-98b4-c346bc85d539	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	QPharma, Inc.	dafe875e-391f-47a2-97b7-89840a760e44	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Onesource Specialty Pharma Limited	438c3d28-8bed-50f0-e063-6394a90a18e4	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: ondansetron hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Onesource Specialty Pharma Limited	a5fe05bc-a7a5-4131-8c4d-2edd113441ec	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: ondansetron hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Atlantic Biologics Corp.	41d71d26-0d42-b368-e063-6394a90add43	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PHOENIX RX LLC	3a79fc2b-9ea3-a808-e063-6394a90ae794	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PHOENIX RX LLC	40106070-6a25-5b0e-e063-6394a90a4197	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0b675b09-fe40-435c-b91a-c61cdf767fbf	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0315	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0315	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0315	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0344	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0344	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0344	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0374	Ondansetron	ondansetron	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-524	Ondansetron	ondansetron	Mylan Institutional Inc.	ANDA	Current
51079-525	Ondansetron	ondansetron	Mylan Institutional Inc.	ANDA	Current
55154-5369	Ondansetron	ondansetron	Cardinal Health	ANDA	Current