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 3 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	Preferred Pharmaceuticals Inc.	36d64400-2d13-4a1a-a1ca-4741cd3d3f1a	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Rising Pharma Holdings, Inc.	90e0e508-75f7-4c8b-bb38-898aa4c531c3	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	426ba54f-199a-41d1-8c27-f827bea56854	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	NorthStar Rx LLC	ac3dfb81-a4c7-4147-9374-c234153b7c51	2025-08-11	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	PHOENIX RX LLC	3a76bae2-04c2-ee2d-e063-6394a90ad4c8	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	57578387-1918-4e56-a564-f14fb22340bf	2025-07-19	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron	ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma Limited	cf10d256-dd89-4a91-a3ed-81db505a79c2	2025-07-08	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON	ONDANSETRON HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	162f2088-9fb1-47e7-b88c-45104be7e7bb	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	Baxter Healthcare Corporation	729d865f-d84a-495e-9456-4bceebb6e03f	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: ONDANSETRON HYDROCHLORIDE generic name: ONDANSETRON HYDROCHLORIDE
ondansetron hydrochloride	ONDANSETRON HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92c758a3-e749-4a15-be4b-ee30b364b2b0	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: ondansetron hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1a0c4dc6-643e-4ee7-92a9-edb98049a5ba	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Precision Dose Inc.	04800a86-2391-44e6-8763-d65e8a916c26	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	f8ada0e4-5c1b-17ab-e053-6294a90a12b8	2025-02-06	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Asclemed USA, Inc.	65b0b2e2-37fd-4d08-9674-954d62bb531a	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b43e15d6-b778-7575-e053-2995a90a93a0	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	AvPAK	e4766235-ac44-ca93-78a6-66d4ded33ada	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products, LLC	2e0b1b09-9e68-4728-82d5-1f86510a0f2a	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products LLC	54e8981e-6880-4d4f-bc46-600c2af59698	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Quality Care Products LLC	89091629-d15e-4e95-aed8-8bc983c78302	2024-12-18	Warnings, Adverse reactions	Name fallback brand name: Ondansetron Hydrochloride generic name: ONDANSETRON HYDROCHLORIDE
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	8585e68b-965f-4f95-a5df-eea023cd5f82	2024-08-21	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